<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/NCT01734928</url>
  </required_header>
  <id_info>
    <org_study_id>CC-4047-MM-007</org_study_id>
    <nct_id>NCT01734928</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma</brief_title>
  <acronym>OPTIMISMM</acronym>
  <official_title>A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy of the combination of pomalidomide,&#xD;
      bortezomib and low dose dexamethasone to the combination of bortezomib and low dose&#xD;
      dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also&#xD;
      assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is&#xD;
      compared to the combination of bortezomib and low dose dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2013</start_date>
  <completion_date type="Actual">May 13, 2022</completion_date>
  <primary_completion_date type="Actual">May 9, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival by Independent Response Adjudication Committee (IRAC)</measure>
    <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
    <description>Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.&#xD;
Progressive Disease is defined as an Increase of ≥ 25% from nadir in:&#xD;
Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g&#xD;
Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)&#xD;
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be &gt; 100 mg/dL.&#xD;
Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h&#xD;
Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium &gt; 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization to date of death, up to approximately 65 months</time_frame>
    <description>Overall survival (OS) is calculated as the time from randomization to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate by Independent Response Adjudication Committee (IRAC)</measure>
    <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
    <description>The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response by Independent Response Adjudication Committee (IRAC)</measure>
    <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
    <description>Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)</measure>
    <time_frame>From first dose to 28 days after the last dose (up to approximately 44 months</time_frame>
    <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)</measure>
    <time_frame>From first dose to 28 days after the last dose (up to approximately 44 months</time_frame>
    <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">559</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Pomalidomide, Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [&gt; 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [&gt; 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.</description>
    <arm_group_label>Pomalidomide, Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <other_name>Oral Pomalidomide</other_name>
    <other_name>CC-4047</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib</intervention_name>
    <description>Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.</description>
    <arm_group_label>Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <arm_group_label>Pomalidomide, Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <other_name>Velcade</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [&gt;75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.</description>
    <arm_group_label>Bortezomib and Low Dose Dexamethasone</arm_group_label>
    <arm_group_label>Pomalidomide, Bortezomib and Low Dose Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be ≥ 18 years at the time of signing informed consent.&#xD;
&#xD;
          -  Must have documented diagnosis of multiple myeloma and have measureable disease by&#xD;
             serum and urine protein electrophoresis.&#xD;
&#xD;
          -  Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.&#xD;
&#xD;
          -  Must have documented disease progression during or after their last anti-myeloma&#xD;
             therapy.&#xD;
&#xD;
          -  All subjects must have received prior treatment with a lenalidomide containing regimen&#xD;
             for at least 2 consecutive cycles.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented progressive disease during therapy or within 60 days of the last dose of a&#xD;
             bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.&#xD;
&#xD;
          -  Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Non-secretory multiple myeloma.&#xD;
&#xD;
          -  Subjects with severe renal impairment requiring dialysis.&#xD;
&#xD;
          -  Previous therapy with pomalidomide.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol Myers-Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amine Bensmaine, MD</last_name>
    <role>Study Director</role>
    <affiliation>Celgene Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southern Cancer Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Comprehensive Cancer Center</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco Fresno Campus</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Oncology Associates</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904-2007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moore UCSD Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Pacific Medical Foundation</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Central Connecticut</name>
      <address>
        <city>Southington</city>
        <state>Connecticut</state>
        <zip>06489</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 153</name>
      <address>
        <city>Southington</city>
        <state>Connecticut</state>
        <zip>06489</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer Institute</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Oncology Associates PA</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Oncology Assoc.</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alves Domenech Oncology and Hematology Clinic</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Beach Cancer Institute, LLC</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 135</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Clinical Research of Indiana, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Kentucky Hematology and Oncology Group, PSC</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care of Maine</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 132</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Agnes - Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229-5299</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Cancer and Blood Disorders</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 125</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Health Research Institute</name>
      <address>
        <city>Hyattsville</city>
        <state>Maryland</state>
        <zip>20782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 299</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 100</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 298</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Medical Center - New Center One</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202-268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 178</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202-268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Hematology Centers of Western Michigan</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Clinical Research Center</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Cancer Center</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Essentia Health Duluth CCOP</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro MN CCOP</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Comprehensive</name>
      <address>
        <city>Jefferson City</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City VA Medical Center University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St John's Mercy Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Clinic Cancerand Hematology - Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Nebraska Cancer Center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CarePoint Health Research Institute</name>
      <address>
        <city>Jersey City</city>
        <state>New Jersey</state>
        <zip>07306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology-Oncology Associates of NNJ, P</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somerset Hematology-Oncology Associates</name>
      <address>
        <city>Somerville</city>
        <state>New Jersey</state>
        <zip>08876</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 186</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-7300</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Institute of Medical Sciences</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boice-Willis Clinic P.A.</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 111</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Systems</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Ohio Oncology Hematology Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Univ of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spartanburg Regional Healthcare System - Gibbs Cancer Center &amp; Research Institute</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avera Research Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 167</name>
      <address>
        <city>Watertown</city>
        <state>South Dakota</state>
        <zip>57201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Lakes Health Care System</name>
      <address>
        <city>Watertown</city>
        <state>South Dakota</state>
        <zip>57201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center - Cancer Institute</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37885</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-5505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 114</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center Francis Street Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78235-8200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 103</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78235-8200</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 130</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joe Arrington Cancer Research and Treatment Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialist</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute at the University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Inst</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Associates</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenatchee Valley Hospital and Clinics</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 139</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>25606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University CTRU</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>25606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 136</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital St. Polten</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 523</name>
      <address>
        <city>St. Pölten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 480</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 481</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital-Center for Hematology and Oncology</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 308</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RSM Durham Regional Cancer Center - Lakeridge Health Oshawa</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSSS Champlain Charles LeMoyne</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 301</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre De Sante Et De Services Sociaux De Rimouski-Neigette</name>
      <address>
        <city>Rimouski</city>
        <state>Quebec</state>
        <zip>G5L5T1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 307</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Local Institution - 304</name>
      <address>
        <city>Halifax</city>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 447</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Copenhagen University Hospital Rigshosptalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 506</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 400</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 499</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Central Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 455</name>
      <address>
        <city>Helsinki</city>
        <zip>290</zip>
        <country>Finland</country>
      </address>
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  <location>
    <facility>
      <name>Hyvinkaa Hospital</name>
      <address>
        <city>Hyvinkaa</city>
        <zip>05850</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 510</name>
      <address>
        <city>Hyvinkaa</city>
        <zip>05850</zip>
        <country>Finland</country>
      </address>
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    <facility>
      <name>Centre Hospitalier de la cote basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 469</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier William Morey</name>
      <address>
        <city>Chalon sur Saone</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 498</name>
      <address>
        <city>Chalon sur Saone</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>CHU Hotel</name>
      <address>
        <city>Grenoble Cedex 09</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 483</name>
      <address>
        <city>Grenoble Cedex 09</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>GH Institut Catholique St Vincent</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille-Hopital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 476</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 486</name>
      <address>
        <city>Nantes</city>
        <zip>44035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite Cedex</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 497</name>
      <address>
        <city>Pierre-Bénite Cedex</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Miletrie</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 516</name>
      <address>
        <city>Poitiers Cedex</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 504</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole</name>
      <address>
        <city>Toulouse Cedex</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hopital Bretonneau</name>
      <address>
        <city>Tours cedex</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 468</name>
      <address>
        <city>Tours cedex</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ChariteUniversitatsmedizinCampus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>D-13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 442</name>
      <address>
        <city>Berlin</city>
        <zip>D-13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 417</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 475</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum EssenInnere Klinik und Poliklinik</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 496</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 430</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 410</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKT Universitaetsklinikum Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Evangelismos</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 484</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 422</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Athens Medical school - Regional General Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 487</name>
      <address>
        <city>Mezourlo</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Larissa</name>
      <address>
        <city>Mezourlo</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Papanikolaou General Hospital of Thessaloniki</name>
      <address>
        <city>Thessloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 465</name>
      <address>
        <city>Thessloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 462</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericordiae University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 7</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 431</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 413</name>
      <address>
        <city>Galway</city>
        <zip>ST46QG</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital Galway</name>
      <address>
        <city>Galway</city>
        <zip>ST46QG</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 457</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 433</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center Department of Hematology</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 449</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 456</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S. Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 415</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ferrarotto</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 403</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Modena</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 451</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara</name>
      <address>
        <city>Pescara</city>
        <zip>65124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 441</name>
      <address>
        <city>Pescara</city>
        <zip>65124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 414</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Sapienza, University of Rome</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 460</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 459</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Casa Sollievo della Sofferenza</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 453</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera S Maria di Terni</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 402</name>
      <address>
        <city>Terni</city>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giovanni Battista</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 401</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hitachi General Hospital</name>
      <address>
        <city>Hitachi, Ibaraki</city>
        <zip>317-0077</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 620</name>
      <address>
        <city>Hitachi, Ibaraki</city>
        <zip>317-0077</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kameda Medical Center</name>
      <address>
        <city>Kamogawa</city>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 625</name>
      <address>
        <city>Kamogawa</city>
        <zip>296-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 626</name>
      <address>
        <city>Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Medical Center</name>
      <address>
        <city>Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japan Red Cross Medical Center</name>
      <address>
        <city>Shibuya-ku</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 623</name>
      <address>
        <city>Shibuya-ku</city>
        <zip>150-8935</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 622</name>
      <address>
        <city>Tachikawa</city>
        <zip>190-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Disaster Medical Center</name>
      <address>
        <city>Tachikawa</city>
        <zip>190-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 514</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 494</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 412</name>
      <address>
        <city>Oslo</city>
        <zip>0372</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo universitetssykehus, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0372</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 411</name>
      <address>
        <city>Brzozow</city>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny w Brzozowie</name>
      <address>
        <city>Brzozow</city>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im dr. Jana Biziela</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 407</name>
      <address>
        <city>Chorzow</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zespol Szpitali Miejskich</name>
      <address>
        <city>Chorzow</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Hematologii Akademii Medycznej w Gdansku</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 463</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 440</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Kliniczny Kliniki Hematologii</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kopernik Memorial Hospital</name>
      <address>
        <city>Lodz</city>
        <zip>93-510</zip>
        <country>Poland</country>
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  <location>
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      <name>Local Institution - 418</name>
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  <location>
    <facility>
      <name>Klinika Hematoonkologii i Transplantacji Szpiku</name>
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        <city>Lublin</city>
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  <location>
    <facility>
      <name>Local Institution - 439</name>
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        <zip>20-081</zip>
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  <location>
    <facility>
      <name>Local Institution - 437</name>
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        <zip>60-569</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego</name>
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        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie</name>
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  <location>
    <facility>
      <name>Local Institution - 448</name>
      <address>
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        <zip>02-781</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Hospital de Braga</name>
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  <location>
    <facility>
      <name>Local Institution - 450</name>
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        <zip>4710-243</zip>
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  <location>
    <facility>
      <name>Instituto Portugues de Oncologia de Lisboa, Francisco Gentil</name>
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  <location>
    <facility>
      <name>Local Institution - 454</name>
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  <location>
    <facility>
      <name>Hospital de Santa Maria</name>
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  <location>
    <facility>
      <name>Local Institution - 466</name>
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  <location>
    <facility>
      <name>Fundacao Champalimaud</name>
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  <location>
    <facility>
      <name>Local Institution - 473</name>
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  <location>
    <facility>
      <name>Local Institution - 464</name>
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        <zip>0</zip>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Local Institution - 425</name>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>Ad-Vance Medical Research, LLC</name>
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  <location>
    <facility>
      <name>City Clinical Hospital 52</name>
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  <location>
    <facility>
      <name>Local Institution - 521</name>
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        <zip>123182</zip>
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  <location>
    <facility>
      <name>Local Institution - 517</name>
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        <zip>125284</zip>
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  <location>
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      <name>Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin</name>
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  <location>
    <facility>
      <name>Local Institution - 520</name>
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  <location>
    <facility>
      <name>State Budgetary Healthcare Institution of Nizhniy Novgorod Region</name>
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  <location>
    <facility>
      <name>Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency</name>
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  <location>
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      <name>Hospital Universitari Germans Trias i Pujol Can Ruti</name>
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  <location>
    <facility>
      <name>Local Institution - 423</name>
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  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
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  <location>
    <facility>
      <name>Local Institution - 424</name>
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      <name>Hospital de Basurto-Osakidetza</name>
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  <location>
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      <name>Hospital 12 de Octubre</name>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
      <name>Local Institution - 526</name>
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    <facility>
      <name>Clinica Universidad de Navarra</name>
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        <zip>31008</zip>
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  <location>
    <facility>
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  <location>
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      <name>Hospital Universitario y Politecnico La Fe</name>
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  <location>
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      <name>Falu lasarett</name>
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  <location>
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      <name>Local Institution - 426</name>
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  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
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  <location>
    <facility>
      <name>Sunderby Sjukhus</name>
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  <location>
    <facility>
      <name>Karolinska University</name>
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  <location>
    <facility>
      <name>Local Institution - 471</name>
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      <name>Sundsvalls sjukhus- Medicinkliniken</name>
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  <location>
    <facility>
      <name>Ankara University Medical Faculty Cebeci Hospital</name>
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      <name>Local Institution - 428</name>
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      <name>Gazi Universitesi Tip Fakultesi Hastanesi</name>
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  <location>
    <facility>
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      <name>Ankara Universitesi Tip Fakultesi</name>
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    <facility>
      <name>Eskisehir Osmangazi University</name>
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    <facility>
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  <location>
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        <zip>0</zip>
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    <facility>
      <name>Gaziantep University</name>
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    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi</name>
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  <location>
    <facility>
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    <facility>
      <name>Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi</name>
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  <location>
    <facility>
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  <location>
    <facility>
      <name>University of Oxford</name>
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      <name>Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit</name>
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      <name>Local Institution - 515</name>
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  <location>
    <facility>
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  <location>
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      <name>Singleton Hospital</name>
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        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 482</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 OPQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 OPQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 436</name>
      <address>
        <city>Worcester</city>
        <zip>WR5 1DD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Worcestershire Acute Hospitals NHS Trust</name>
      <address>
        <city>Worcester</city>
        <zip>WR5 1DD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Australia</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>May 9, 2023</results_first_submitted>
  <results_first_submitted_qc>June 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2023</results_first_posted>
  <last_update_submitted>June 5, 2023</last_update_submitted>
  <last_update_submitted_qc>June 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Pomalidomide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT01734928/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>548 participants treated</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment 1: POM+BTZ+LD-DEX</title>
          <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>Treatment 2: BTZ+LD-DEX</title>
          <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="281"/>
                <participants group_id="P2" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="270"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>clinical progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew informed consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomization error</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="270"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
                <participants group_id="P2" count="270"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="165"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment 1: POM+BTZ+LD-DEX</title>
          <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>Treatment 2: BTZ+LD-DEX</title>
          <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="281"/>
            <count group_id="B2" value="278"/>
            <count group_id="B3" value="559"/>
          </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="65.9" spread="10.13"/>
                    <measurement group_id="B2" value="66.1" spread="10.16"/>
                    <measurement group_id="B3" value="66.0" spread="10.14"/>
                  </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="126"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="257"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="244"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="485"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="237"/>
                    <measurement group_id="B2" value="234"/>
                    <measurement group_id="B3" value="471"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival by Independent Response Adjudication Committee (IRAC)</title>
        <description>Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.&#xD;
Progressive Disease is defined as an Increase of ≥ 25% from nadir in:&#xD;
Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g&#xD;
Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)&#xD;
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be &gt; 100 mg/dL.&#xD;
Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h&#xD;
Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium &gt; 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.</description>
        <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival by Independent Response Adjudication Committee (IRAC)</title>
          <description>Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.&#xD;
Progressive Disease is defined as an Increase of ≥ 25% from nadir in:&#xD;
Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g&#xD;
Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)&#xD;
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be &gt; 100 mg/dL.&#xD;
Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h&#xD;
Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium &gt; 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.</description>
          <population>All randomized participants</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="281"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.20" lower_limit="9.66" upper_limit="13.73"/>
                    <measurement group_id="O2" value="7.10" lower_limit="5.88" upper_limit="8.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Based on Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival (OS) is calculated as the time from randomization to death from any cause.</description>
        <time_frame>From randomization to date of death, up to approximately 65 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival (OS) is calculated as the time from randomization to death from any cause.</description>
          <population>All randomized participants</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="281"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.58" lower_limit="28.55" upper_limit="41.20"/>
                    <measurement group_id="O2" value="31.61" lower_limit="26.05" upper_limit="37.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.571</p_value>
            <method>Log Rank</method>
            <method_desc>The p-value is based on a stratified log-rank test with stratification factors as above Cox model.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate by Independent Response Adjudication Committee (IRAC)</title>
        <description>The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
        <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate by Independent Response Adjudication Committee (IRAC)</title>
          <description>The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
          <population>All randomized participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stringent complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Reponse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Good Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response by Independent Response Adjudication Committee (IRAC)</title>
        <description>Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
        <time_frame>From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months</time_frame>
        <population>All randomized participants with a response (sCR or CR or VGPR or PR)</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response by Independent Response Adjudication Committee (IRAC)</title>
          <description>Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.&#xD;
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow&#xD;
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence&#xD;
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level &lt; 100 mg per 24 hours&#xD;
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to &lt; 200 mg per 24 hours&#xD;
Progressive Disease: Please refer to Primary outcome measure for definition&#xD;
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease</description>
          <population>All randomized participants with a response (sCR or CR or VGPR or PR)</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="231"/>
                <count group_id="O2" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.70" lower_limit="10.94" upper_limit="18.10"/>
                    <measurement group_id="O2" value="10.94" lower_limit="8.11" upper_limit="14.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.064</p_value>
            <method>Unstratified log-rank test</method>
            <method_desc>The p-value is based on an unstratified log-rank test.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
            <estimate_desc>Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)</title>
        <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
        <time_frame>From first dose to 28 days after the last dose (up to approximately 44 months</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)</title>
          <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
          <population>All Treated Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)</title>
        <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
        <time_frame>From first dose to 28 days after the last dose (up to approximately 44 months</time_frame>
        <population>All Treated Participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment 1: POM+BTZ+LD-DEX</title>
            <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Treatment 2: BTZ+LD-DEX</title>
            <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)</title>
          <description>Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.</description>
          <population>All Treated Participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.</time_frame>
      <desc>The number at Risk for All-Cause Mortality represents all Randomized Participants.&#xD;
The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment 1: POM + BTZ + LD-DEX</title>
          <description>POM (Pomalidomide)&#xD;
4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>Treatment 2: BTZ + LD-DEX</title>
          <description>BTZ ((Bortezomib)&#xD;
For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle&#xD;
For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone)&#xD;
For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle.&#xD;
For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (&gt; 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="197" subjects_at_risk="281"/>
                <counts group_id="E2" subjects_affected="193" subjects_at_risk="278"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="177" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="119" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hyperviscosity syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Restrictive cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Retinal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Colonic fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastric volvulus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Parotid gland enlargement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Acute hepatitis B</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchitis pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Enterobacter pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Enterococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>H1N1 influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Haemophilus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Herpes oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Leishmaniasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Mastoiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Meningitis listeria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Meningococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Muscle abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia haemophilus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia moraxella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia parainfluenzae viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary tract infection staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Chest X-ray abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Coronavirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Osteorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute lymphocytic leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Basosquamous carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Plasma cell leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Plasmacytoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Porocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Scrotal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Motor dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Nerve root compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Anuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary bladder haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory alkalosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>20.0</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="276" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="260" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="150" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="110" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="105" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="106" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="102" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="107" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="134" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="103" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="270"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="278"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="270"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email</phone>
      <email>Clinical.Trials@bms.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/NCT01734928
org study id: CC-4047-MM-007
nct id: NCT01734928
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the efficacy of the combination of pomalidomide,
      bortezomib and low dose dexamethasone to the combination of bortezomib and low dose
      dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also
      assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is
      compared to the combination of bortezomib and low dose dexamethasone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival by Independent Response Adjudication Committee (IRAC)
time frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
description: Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death.
Progressive Disease is defined as an Increase of ≥ 25% from nadir in:
Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g
Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours)
In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL.
Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h
Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
measure: Overall Survival (OS)
time frame: From randomization to date of death, up to approximately 65 months
description: Overall survival (OS) is calculated as the time from randomization to death from any cause.
measure: Overall Response Rate by Independent Response Adjudication Committee (IRAC)
time frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
description: The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined.
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
Progressive Disease: Please refer to Primary outcome measure for definition
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
measure: Duration of Response by Independent Response Adjudication Committee (IRAC)
time frame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
description: Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first.
Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow
SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours
PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
Progressive Disease: Please refer to Primary outcome measure for definition
SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
measure: Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
time frame: From first dose to 28 days after the last dose (up to approximately 44 months
description: Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
measure: Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
time frame: From first dose to 28 days after the last dose (up to approximately 44 months
description: Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
arm group label: Pomalidomide, Bortezomib and Low Dose Dexamethasone
arm group type: Experimental
description: 4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.
arm group label: Bortezomib and Low Dose Dexamethasone
arm group type: Active Comparator
description: 1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
intervention type: Drug
intervention name: Pomalidomide
description: Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
arm group label: Pomalidomide, Bortezomib and Low Dose Dexamethasone
other name: Oral Pomalidomide
other name: CC-4047
intervention type: Drug
intervention name: Bortezomib
description: Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
arm group label: Bortezomib and Low Dose Dexamethasone
arm group label: Pomalidomide, Bortezomib and Low Dose Dexamethasone
other name: Velcade
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
arm group label: Bortezomib and Low Dose Dexamethasone
arm group label: Pomalidomide, Bortezomib and Low Dose Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol Myers-Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
last name: Amine Bensmaine, MD
role: Study Director
affiliation: Celgene Corporation
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country: Austria
country: Canada
country: Denmark
country: Finland
country: France
country: Germany
country: Greece
country: Ireland
country: Israel
country: Italy
country: Japan
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Puerto Rico
country: Russian Federation
country: Spain
country: Sweden
country: Turkey
country: United Kingdom
country: United States
country: Argentina
country: Australia
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Thalidomide
mesh term: Dexamethasone
mesh term: Bortezomib
mesh term: Pomalidomide
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 