<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/NCT02205333</url>
  </required_header>
  <id_info>
    <org_study_id>D4981C00001</org_study_id>
    <nct_id>NCT02205333</nct_id>
  </id_info>
  <brief_title>A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies</brief_title>
  <acronym>MEDI6469</acronym>
  <official_title>A Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination With Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects With Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to determine the best dose of MEDI6469 that is safe and&#xD;
      tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736&#xD;
      (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large&#xD;
      B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469&#xD;
      in a set of participants with advanced solid tumors while rituximab will be tested with&#xD;
      MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants&#xD;
      with advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated early at the sponsor's discretion.&#xD;
  </why_stopped>
  <start_date type="Actual">August 13, 2014</start_date>
  <completion_date type="Actual">April 8, 2016</completion_date>
  <primary_completion_date type="Actual">April 8, 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Maximum Tolerated Dose (MTD) of MEDI6469</measure>
    <time_frame>From the first dose of study treatment through 28 days after the first dose (up to 28 days)</time_frame>
    <description>The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With DLTs</measure>
    <time_frame>From the first dose of study treatment through 28 days after the first dose (up to 28 days)</time_frame>
    <description>The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any &gt;=Grade 2 pneumonitis that did not resolve to &lt;=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (&lt;=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to &lt;=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (&gt;=) Grade 3 lymphopenia (unless clinically significant).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
    <description>An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Serious Adverse Events</measure>
    <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
    <description>A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</measure>
    <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
    <description>Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs</measure>
    <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
    <description>Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs</measure>
    <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
    <description>Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR)</measure>
    <time_frame>From study entry until early termination (up to 1 year)</time_frame>
    <description>Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From study entry until early termination (up to 1 year)</time_frame>
    <description>Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment &gt;= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>From study entry until early termination (up to 1 year)</time_frame>
    <description>Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for &gt;= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
    <description>Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
    <description>Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
    <description>The OS was the duration from the start of study treatment until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax)</measure>
    <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment</time_frame>
    <description>The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)</measure>
    <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
    <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Clearance (CL)</measure>
    <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
    <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Phase Elimination Half-Life (T1/2)</measure>
    <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
    <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)</measure>
    <time_frame>All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)</time_frame>
    <description>The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <condition>Aggressive B-cell Lymphomas</condition>
  <arm_group>
    <arm_group_label>MEDI6469 6 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 2 mg/kg+Tremelimumab 3 mg/k</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1 then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1 then Q4W for 6 doses after which Q12W for 2 doses or until progression of disease (PD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1 then every 2 weeks (Q2W) for 12 months or until PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 2 mg/kg+Rituximab 375 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI6469 10 mg/kg+Rituximab 375 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI6469 Monotherapy</intervention_name>
    <description>single intravenous (IV) administration of MEDI6469</description>
    <arm_group_label>MEDI6469 10 mg/kg</arm_group_label>
    <arm_group_label>MEDI6469 6 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI6469 Plus Tremelimumab</intervention_name>
    <description>MEDI6469 in combination with Tremelimumab</description>
    <arm_group_label>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</arm_group_label>
    <arm_group_label>MEDI6469 2 mg/kg+Tremelimumab 3 mg/k</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI6469 Plus Durvalumab</intervention_name>
    <description>MEDI6469 in combination with Durvalumab</description>
    <arm_group_label>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</arm_group_label>
    <arm_group_label>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</arm_group_label>
    <arm_group_label>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI6469 plus Rituximab</intervention_name>
    <description>MEDI6469 in combination with Rituximab</description>
    <arm_group_label>MEDI6469 10 mg/kg+Rituximab 375 mg/m^2</arm_group_label>
    <arm_group_label>MEDI6469 2 mg/kg+Rituximab 375 mg/m^2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt;/= 18 years old&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced solid tumors that are refractory to&#xD;
             standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A&#xD;
             and B)&#xD;
&#xD;
          -  At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in&#xD;
             Cohorts A and B)&#xD;
&#xD;
          -  Histologically confirmed DLBCL(Cohort C)&#xD;
&#xD;
          -  Adequate organ and marrow function&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  Willingness to provide consent for biopsy samples&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior exposure to immunotherapy (either as a single agent or in combination) including&#xD;
             but not limited to CD137 or OX40 agonists, anti-CTLA-4, anti-PD-1, or anti-PD-L1,&#xD;
             anti-PD-L2 antibody or pathway-targeting agents&#xD;
&#xD;
          -  History of organ transplant that requires use of immunosuppressives&#xD;
&#xD;
          -  History of primary immunodeficiency or tuberculosis&#xD;
&#xD;
          -  Active or prior documented autoimmune disease within the past 3 years&#xD;
&#xD;
          -  Active or chronic viral hepatitis or history of any type of hepatitis within the last&#xD;
             6 months&#xD;
&#xD;
          -  Major surgical procedure within 30 days prior to the first dose of investigational&#xD;
             product or still recovering from prior surgery&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MedImmune, LLC</last_name>
    <role>Study Director</role>
    <affiliation>MedImmune LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Washington, D.C.</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>7601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <results_first_submitted>March 27, 2017</results_first_submitted>
  <results_first_submitted_qc>March 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 8, 2017</results_first_posted>
  <last_update_submitted>June 1, 2017</last_update_submitted>
  <last_update_submitted_qc>June 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Advanced Solid tumors</keyword>
  <keyword>Diffuse Large B-cell Lymphoma</keyword>
  <keyword>programmed death 1</keyword>
  <keyword>programmed dealth ligand 1</keyword>
  <keyword>cytotoxic T-lymphocyte-associated antigen-4</keyword>
  <keyword>OX40 ligand</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Tremelimumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 58 participants were screened at 13 sites in the United States of America (USA).</recruitment_details>
      <pre_assignment_details>A total of 58 participants were screened for this study, of which 48 participants were enrolled and received study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MEDI6469 6 Milligram/Kilogram (mg/kg)</title>
          <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
        </group>
        <group group_id="P2">
          <title>MEDI6469 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
        </group>
        <group group_id="P3">
          <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
        </group>
        <group group_id="P4">
          <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
        </group>
        <group group_id="P5">
          <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
        </group>
        <group group_id="P6">
          <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="P7">
          <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="P8">
          <title>MEDI6469 2 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
        <group group_id="P9">
          <title>MEDI6469 10 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MEDI6469 6 Milligram/Kilogram (mg/kg)</title>
          <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
        </group>
        <group group_id="B2">
          <title>MEDI6469 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
        </group>
        <group group_id="B3">
          <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
        </group>
        <group group_id="B4">
          <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
        </group>
        <group group_id="B5">
          <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
        </group>
        <group group_id="B6">
          <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="B7">
          <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="B8">
          <title>MEDI6469 2 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
        <group group_id="B9">
          <title>MEDI6469 10 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
        <group group_id="B10">
          <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="8"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="3"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="7"/>
            <count group_id="B7" value="7"/>
            <count group_id="B8" value="3"/>
            <count group_id="B9" value="1"/>
            <count group_id="B10" 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="60.5" spread="12.6"/>
                    <measurement group_id="B2" value="63.8" spread="8.9"/>
                    <measurement group_id="B3" value="48.0" spread="6.9"/>
                    <measurement group_id="B4" value="61.3" spread="8.7"/>
                    <measurement group_id="B5" value="57.5" spread="19.4"/>
                    <measurement group_id="B6" value="66.6" spread="14.5"/>
                    <measurement group_id="B7" value="62.6" spread="9.1"/>
                    <measurement group_id="B8" value="70.3" spread="4.6"/>
                    <measurement group_id="B9" value="73.0" spread="NA">Not evaluable due to insufficient number of participants.</measurement>
                    <measurement group_id="B10" value="61.9" spread="12.2"/>
                  </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="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Tolerated Dose (MTD) of MEDI6469</title>
        <description>The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.</description>
        <time_frame>From the first dose of study treatment through 28 days after the first dose (up to 28 days)</time_frame>
        <population>DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Tolerated Dose (MTD) of MEDI6469</title>
          <description>The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.</description>
          <population>DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.</population>
          <units>milligram per kilogram (mg/kg)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Dose escalation was completed without determination of MTD.</measurement>
                    <measurement group_id="O2" value="NA">Dose escalation was completed without determination of MTD.</measurement>
                    <measurement group_id="O3" value="NA">Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.</measurement>
                    <measurement group_id="O4" value="NA">Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.</measurement>
                    <measurement group_id="O5" value="NA">Dose escalation was completed without determination of MTD.</measurement>
                    <measurement group_id="O6" value="NA">Dose escalation was completed without determination of MTD.</measurement>
                    <measurement group_id="O7" value="NA">Dose escalation was completed without determination of MTD.</measurement>
                    <measurement group_id="O8" value="NA">Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.</measurement>
                    <measurement group_id="O9" value="NA">Dose escalation was terminated early prior to completion of the protocol-specified dose ranges.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With DLTs</title>
        <description>The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any &gt;=Grade 2 pneumonitis that did not resolve to &lt;=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (&lt;=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to &lt;=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (&gt;=) Grade 3 lymphopenia (unless clinically significant).</description>
        <time_frame>From the first dose of study treatment through 28 days after the first dose (up to 28 days)</time_frame>
        <population>DLT-evaluable population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With DLTs</title>
          <description>The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any &gt;=Grade 2 pneumonitis that did not resolve to &lt;=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (&lt;=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to &lt;=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (&gt;=) Grade 3 lymphopenia (unless clinically significant).</description>
          <population>DLT-evaluable population</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.</description>
        <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
        <population>As-treated population: all the participants who received any study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.</description>
          <population>As-treated population: all the participants who received any study treatment.</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Serious Adverse Events</title>
        <description>A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.</description>
        <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Serious Adverse Events</title>
          <description>A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.</description>
          <population>As-treated population</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</title>
        <description>Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.</description>
        <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs</title>
          <description>Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.</description>
          <population>As-treated population</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood iron decreased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte count decreased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count decreased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thrombocytopenia</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypernatremia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypomagnesemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood alkaline phosphatase increased</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood creatinine increased</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyltransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypercalcemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperkalemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoalbuminemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperuricemia</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood bilirubin increased</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypophosphatemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood cholesterol increased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood glucose increased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood thyroid stimulating hormone increased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypocalcemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypothyroidism</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Iron deficiency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver function test increased</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tri-iodothyronine free decreased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Troponin increased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thyroxine free decreased</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematuria</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activated partial thromboplastin time prolonged</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs</title>
        <description>Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.</description>
        <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs</title>
          <description>Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.</description>
          <population>As-treated population</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypotension</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus tachycardia</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea exertional</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tachycardia</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bradycardia</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoxia</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wheezing</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs</title>
        <description>Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.</description>
        <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs</title>
          <description>Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.</description>
          <population>As-treated population</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response (BOR)</title>
        <description>Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
        <time_frame>From study entry until early termination (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response (BOR)</title>
          <description>Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
          <population>As-treated population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CR</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="16.7"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="28.6"/>
                    <measurement group_id="O5" value="33.3"/>
                    <measurement group_id="O6" value="14.3"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="33.3"/>
                    <measurement group_id="O9" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="33.3"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="42.9"/>
                    <measurement group_id="O5" value="50.0"/>
                    <measurement group_id="O6" value="42.9"/>
                    <measurement group_id="O7" value="100.0"/>
                    <measurement group_id="O8" value="66.7"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5"/>
                    <measurement group_id="O2" value="66.7"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="28.6"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="42.9"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment &gt;= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.</description>
        <time_frame>From study entry until early termination (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment &gt;= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.</description>
          <population>As-treated population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="16.7"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate</title>
        <description>Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for &gt;= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
        <time_frame>From study entry until early termination (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate</title>
          <description>Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for &gt;= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
          <population>As-treated population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="33.3"/>
                    <measurement group_id="O4" value="28.6"/>
                    <measurement group_id="O5" value="50.0"/>
                    <measurement group_id="O6" value="14.3"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="33.3"/>
                    <measurement group_id="O9" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
        <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
        <population>All the participants with an OR were included.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
          <population>All the participants with an OR were included.</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
        <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.</description>
          <population>As-treated population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="0.9" upper_limit="3.5"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.8" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.9" lower_limit="1.8" upper_limit="6.4"/>
                    <measurement group_id="O4" value="2.8" lower_limit="0.7" upper_limit="6.7"/>
                    <measurement group_id="O5" value="5.6" lower_limit="1.0" upper_limit="17.8"/>
                    <measurement group_id="O6" value="1.8" lower_limit="1.0" upper_limit="6.4"/>
                    <measurement group_id="O7" value="1.4" lower_limit="1.0" upper_limit="1.8"/>
                    <measurement group_id="O8" value="1.0" lower_limit="0.9" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O9" value="5.4" lower_limit="NA" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>The OS was the duration from the start of study treatment until death due to any cause.</description>
        <time_frame>From Study entry until early termination (up to 1 year)</time_frame>
        <population>As-treated population</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>The OS was the duration from the start of study treatment until death due to any cause.</description>
          <population>As-treated population</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="0.9" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O2" value="6.5" lower_limit="1.8" upper_limit="10.7"/>
                    <measurement group_id="O3" value="13.1" lower_limit="11.2" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O4" value="6.7" lower_limit="2.0" upper_limit="12.5"/>
                    <measurement group_id="O5" value="11.2" lower_limit="1.2" upper_limit="17.8"/>
                    <measurement group_id="O6" value="NA" lower_limit="1.0" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O7" value="2.9" lower_limit="2.5" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O8" value="3.3" lower_limit="1.7" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                    <measurement group_id="O9" value="NA" lower_limit="NA" upper_limit="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax)</title>
        <description>The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
        <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment</time_frame>
        <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax)</title>
          <description>The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
          <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
          <units>microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.76" spread="34.87"/>
                    <measurement group_id="O2" value="188.87" spread="59.88"/>
                    <measurement group_id="O3" value="49.00" spread="1.29"/>
                    <measurement group_id="O4" value="43.67" spread="7.99"/>
                    <measurement group_id="O5" value="40.21" spread="8.20"/>
                    <measurement group_id="O6" value="42.10" spread="6.63"/>
                    <measurement group_id="O7" value="234.91" spread="56.05"/>
                    <measurement group_id="O8" value="31.68" spread="5.06"/>
                    <measurement group_id="O9" value="289.40" spread="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)</title>
        <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
        <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
        <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)</title>
          <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
          <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
          <units>day*microgram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556.92" spread="166.95"/>
                    <measurement group_id="O2" value="873.16" spread="328.74"/>
                    <measurement group_id="O3" value="169.34" spread="18.15"/>
                    <measurement group_id="O4" value="183.09" spread="26.27"/>
                    <measurement group_id="O5" value="144.91" spread="33.07"/>
                    <measurement group_id="O6" value="169.65" spread="45.98"/>
                    <measurement group_id="O7" value="998.25" spread="400.12"/>
                    <measurement group_id="O8" value="145.55" spread="16.86"/>
                    <measurement group_id="O9" value="1619.73" spread="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Systemic Clearance (CL)</title>
        <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
        <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
        <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Systemic Clearance (CL)</title>
          <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
          <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
          <units>liter per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="0.224"/>
                    <measurement group_id="O2" value="0.84" spread="0.246"/>
                    <measurement group_id="O3" value="1.02" spread="0.155"/>
                    <measurement group_id="O4" value="0.89" spread="0.132"/>
                    <measurement group_id="O5" value="1.04" spread="0.288"/>
                    <measurement group_id="O6" value="1.0" spread="0.266"/>
                    <measurement group_id="O7" value="0.84" spread="0.173"/>
                    <measurement group_id="O8" value="1.11" spread="0.188"/>
                    <measurement group_id="O9" value="0.77" spread="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Phase Elimination Half-Life (T1/2)</title>
        <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
        <time_frame>MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.</time_frame>
        <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Phase Elimination Half-Life (T1/2)</title>
          <description>The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469</description>
          <population>All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.</population>
          <units>Day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" spread="0.83"/>
                    <measurement group_id="O2" value="3.20" spread="1.23"/>
                    <measurement group_id="O3" value="1.56" spread="0.04"/>
                    <measurement group_id="O4" value="2.86" spread="0.68"/>
                    <measurement group_id="O5" value="2.73" spread="0.65"/>
                    <measurement group_id="O6" value="3.30" spread="0.68"/>
                    <measurement group_id="O7" value="2.98" spread="1.06"/>
                    <measurement group_id="O8" value="3.75" spread="1.03"/>
                    <measurement group_id="O9" value="4.19" spread="NA">Not evaluable due to insufficient number of participants achieved this endpoint</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)</title>
        <description>The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).</description>
        <time_frame>All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)</time_frame>
        <population>All the participants who received at least a one dose of MEDI6469.</population>
        <group_list>
          <group group_id="O1">
            <title>MEDI6469 6 mg/kg</title>
            <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
          </group>
          <group group_id="O2">
            <title>MEDI6469 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
          </group>
          <group group_id="O3">
            <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
          </group>
          <group group_id="O4">
            <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
          </group>
          <group group_id="O5">
            <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
          </group>
          <group group_id="O6">
            <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O7">
            <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
            <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
          </group>
          <group group_id="O8">
            <title>MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
          <group group_id="O9">
            <title>MEDI6469 10 mg/kg + Rituximab 375 mg/m^2</title>
            <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)</title>
          <description>The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).</description>
          <population>All the participants who received at least a one dose of MEDI6469.</population>
          <units>Participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MEDI6469 6 Milligram/Kilogram (mg/kg)</title>
          <description>Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1</description>
        </group>
        <group group_id="E2">
          <title>MEDI6469 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1</description>
        </group>
        <group group_id="E3">
          <title>MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD</description>
        </group>
        <group group_id="E4">
          <title>MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD</description>
        </group>
        <group group_id="E5">
          <title>MEDI6469 2 mg/kg+Durvalumab 3 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD</description>
        </group>
        <group group_id="E6">
          <title>MEDI6469 2 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="E7">
          <title>MEDI6469 10 mg/kg+Durvalumab 10 mg/kg</title>
          <description>Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD</description>
        </group>
        <group group_id="E8">
          <title>MEDI6469 2 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
        <group group_id="E9">
          <title>MEDI6469 10 mg/kg+Rituximab 375 mg/m^2</title>
          <description>Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myoclonus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Obstructive uropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="9" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E5" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="4" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour flare</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="3" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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>MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated early at the Sponsor's discretion.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Victoria Chiou</name_or_title>
      <organization>MedImmune, LLC</organization>
      <phone>301-398-4330</phone>
      <email>chiouv@MedImmune.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/NCT02205333
org study id: D4981C00001
nct id: NCT02205333
lead sponsor: 
has dmc: No
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and
      tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736
      (durvalumab), or rituximab in participants with either advanced solid tumors or diffuse large
      B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 (durvalumab) will be tested with MEDI6469
      in a set of participants with advanced solid tumors while rituximab will be tested with
      MEDI6469 in participants with DLBCL. MEDI6469 will be tested as monotherapy in participants
      with advanced solid tumors.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose (MTD) of MEDI6469
time frame: From the first dose of study treatment through 28 days after the first dose (up to 28 days)
description: The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.
measure: Number of Participants With DLTs
time frame: From the first dose of study treatment through 28 days after the first dose (up to 28 days)
description: The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
description: An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.
measure: Number of Participants With Treatment-emergent Serious Adverse Events
time frame: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
description: A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
time frame: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
description: Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.
measure: Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs
time frame: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
description: Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs
time frame: From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)
description: Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.
measure: Best Overall Response (BOR)
time frame: From study entry until early termination (up to 1 year)
description: Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.
measure: Objective Response Rate (ORR)
time frame: From study entry until early termination (up to 1 year)
description: Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.
measure: Disease Control Rate
time frame: From study entry until early termination (up to 1 year)
description: Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.
measure: Duration of Response (DOR)
time frame: From Study entry until early termination (up to 1 year)
description: Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
measure: Progression-free Survival (PFS)
time frame: From Study entry until early termination (up to 1 year)
description: Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.
measure: Overall Survival (OS)
time frame: From Study entry until early termination (up to 1 year)
description: The OS was the duration from the start of study treatment until death due to any cause.
measure: Maximum Observed Serum Concentration (Cmax)
time frame: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment
description: The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
measure: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
time frame: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
description: The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
measure: Systemic Clearance (CL)
time frame: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
description: The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
measure: Terminal Phase Elimination Half-Life (T1/2)
time frame: MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.
description: The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469
measure: Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)
time frame: All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)
description: The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).
arm group label: MEDI6469 6 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 6 milligram/kilogram (mg/kg) as a single intravenous (IV) administration on Day 1
arm group label: MEDI6469 10 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
arm group label: MEDI6469 2 mg/kg+Tremelimumab 3 mg/k
arm group type: Experimental
description: Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1 then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
arm group label: MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1 then Q4W for 6 doses after which Q12W for 2 doses or until progression of disease (PD)
arm group label: MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1 then every 2 weeks (Q2W) for 12 months or until PD
arm group label: MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
arm group label: MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
arm group type: Experimental
description: Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
arm group label: MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
arm group type: Experimental
description: Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
arm group label: MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
arm group type: Experimental
description: Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
intervention type: Biological
intervention name: MEDI6469 Monotherapy
description: single intravenous (IV) administration of MEDI6469
arm group label: MEDI6469 10 mg/kg
arm group label: MEDI6469 6 mg/kg
intervention type: Biological
intervention name: MEDI6469 Plus Tremelimumab
description: MEDI6469 in combination with Tremelimumab
arm group label: MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg
arm group label: MEDI6469 2 mg/kg+Tremelimumab 3 mg/k
intervention type: Biological
intervention name: MEDI6469 Plus Durvalumab
description: MEDI6469 in combination with Durvalumab
arm group label: MEDI6469 10 mg/kg+Durvalumab 10 mg/kg
arm group label: MEDI6469 2 mg/kg+Durvalumab 10 mg/kg
arm group label: MEDI6469 2 mg/kg+Durvalumab 3 mg/kg
intervention type: Biological
intervention name: MEDI6469 plus Rituximab
description: MEDI6469 in combination with Rituximab
arm group label: MEDI6469 10 mg/kg+Rituximab 375 mg/m^2
arm group label: MEDI6469 2 mg/kg+Rituximab 375 mg/m^2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: MedImmune, LLC
role: Study Director
affiliation: MedImmune LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Aggression
mesh term: Rituximab
mesh term: Durvalumab
mesh term: Tremelimumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated early at the Sponsor's discretion.
point of contact: 