<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01712789</url>
  </required_header>
  <id_info>
    <org_study_id>CC-4047-MM-010</org_study_id>
    <secondary_id>2012-001888-78</secondary_id>
    <nct_id>NCT01712789</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma</brief_title>
  <acronym>STRATUS</acronym>
  <official_title>A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and 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 primary purpose of the study is to evaluate the safety and efficacy and to generate PK&#xD;
      and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients&#xD;
      with refractory or relapsed and refractory multiple myeloma.&#xD;
&#xD;
      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment&#xD;
      phase and a Follow-up phase which starts within 28 days of discontinuation from study&#xD;
      treatment, every 3 months for up to 5 years.&#xD;
&#xD;
      In addition, the collection of steady-state PK data from a large population will enable&#xD;
      robust population PK and assess Pomalidomide exposure response analyses.&#xD;
&#xD;
      The exploratory objectives of the study are to investigate potential markers predictive of&#xD;
      POM response or resistance and pharmacodynamic markers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2012</start_date>
  <completion_date type="Actual">December 11, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAE)</measure>
    <time_frame>From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.</time_frame>
    <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.&#xD;
A SAE = AE occurring at any dose that:&#xD;
Results in death;&#xD;
Is life-threatening&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant disability/incapacity&#xD;
Is a congenital anomaly/birth defect</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response</measure>
    <time_frame>Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks</time_frame>
    <description>Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks</time_frame>
    <description>Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan Meier Estimate of Duration of Response</measure>
    <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
    <description>Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines</measure>
    <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
    <description>Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan Meier Estimate of Time to Progression</measure>
    <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
    <description>Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan Meier Estimate of Overall Survival (OS)</measure>
    <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
    <description>Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)</measure>
    <time_frame>Cycles 1, 2, 3, 4, 5, 6</time_frame>
    <description>Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pomalidomide Exposure - Apparent Volume of Distribution (V/F)</measure>
    <time_frame>Cycles 1, 2, 3, 4, 5, 6</time_frame>
    <description>Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytogenetic Analysis</measure>
    <time_frame>Study entry</time_frame>
    <description>Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">682</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Pomalidomide plus Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide</intervention_name>
    <description>Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle</description>
    <arm_group_label>Pomalidomide plus Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.</description>
    <arm_group_label>Pomalidomide plus Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years old, who must understand and voluntarily sign an Informed Consent.&#xD;
&#xD;
          -  Patients must have documented diagnosis of Multiple Myeloma and have measurable&#xD;
             disease.&#xD;
&#xD;
          -  Patients must have undergone prior treatment with ≥ 2 treatments lines, of&#xD;
             anti-myeloma therapy.&#xD;
&#xD;
          -  Patients must have either refractory or relapsed and refractory disease.&#xD;
&#xD;
          -  Patients must have received at least 2 consecutive cycles of prior treatment that&#xD;
             include lenalidomide and bortezomib, either alone or in combination regimens.&#xD;
&#xD;
          -  Patients must have received adequate alkylator therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of malignancies, other than Multiple Myeloma.&#xD;
&#xD;
          -  Previous therapy with Pomalidomide, hypersensitivity to thalidomide and lenalidomide&#xD;
             or dexamethasone.&#xD;
&#xD;
          -  Patients who received an allogeneic bone marrow or allogeneic peripheral blood stem&#xD;
             cell transplant.&#xD;
&#xD;
          -  Patients who are planning for or who are eligible for stem cell transplant.&#xD;
&#xD;
          -  Patients who received major surgery and any anti-myeloma drug therapy within the last&#xD;
             14 days of starting study treatment.&#xD;
&#xD;
          -  Patients with a current disease that can interfere with protocol procedures or study&#xD;
             treatment.&#xD;
&#xD;
          -  Patients unable or unwilling to undergo antithrombotic prophylactic treatment.&#xD;
&#xD;
          -  Pregnant or breastfeeding females.&#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>Teresa Peluso, MBBS, DCPSA</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>A-8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ St-Jan Brugge Oostende AV</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VUB Vrije Universiteit Brussel</name>
      <address>
        <city>Brussel</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Liege</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mont -Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</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>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</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>Tartu University Hospital Clinic</name>
      <address>
        <city>Tartu</city>
        <zip>51014</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsingin yliopistollinen keskussairaala</name>
      <address>
        <city>Helsinki</city>
        <zip>FI-00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <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>Hopital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital A. Michallon</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette Hematologie</name>
      <address>
        <city>Marseille cedex</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hotel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service Hemato-Immunologie Hopital St Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims cedex</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematologie - CHU Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</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>CHU Nancy Hematology</name>
      <address>
        <city>Vandoeuvre les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite, Campus Benjamin Franklin Universitatsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>D-09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie</name>
      <address>
        <city>Dusseldorf</city>
        <zip>D-40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Essen-</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik</name>
      <address>
        <city>Freiburg</city>
        <zip>D-79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abt Haematologie - Onkologie / Allg. Krankenhaus Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>D-22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>O7740</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Schleswig Holstein</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universitat zu Koln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik MuensterMedizinische Klinik A</name>
      <address>
        <city>Muenster</city>
        <zip>48129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TU München - Klinikum rechts der Isar</name>
      <address>
        <city>München</city>
        <zip>81675</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>University Hospital of Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Wurzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University HospitalHaematology Consultant</name>
      <address>
        <city>Wilton</city>
        <state>Cork</state>
        <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>University Hospital Galway</name>
      <address>
        <city>Galway</city>
        <zip>ST46QG</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Ancona</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Policlinico - Università di Bari</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</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>Fondazione IRCCS Istituto Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda, Milano</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa di Cura La Maddalena</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile di Piacenza</name>
      <address>
        <city>Piacenza</city>
        <zip>29100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sant'Eugenio</name>
      <address>
        <city>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Bortolo</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU University Medical Center VU Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haga Hospital</name>
      <address>
        <city>Den Haag</city>
        <zip>2545 CH</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>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo University Hospital, Rikshospitalet HF</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital Trondheim</name>
      <address>
        <city>Trondheim</city>
        <zip>N-7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii</name>
      <address>
        <city>Gdansk</city>
        <zip>80-211</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitala Uniwersyteckiego w. Krakowie</name>
      <address>
        <city>Kraków</city>
        <zip>31 501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Hematologii i Transfuzjologii w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia de Lisboa</name>
      <address>
        <city>Lisboa</city>
        <zip>1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Geral de Santo António - Serviço de Hematologia Clínica</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bratislava - Hospital Ss Cyril and Methodius</name>
      <address>
        <city>Bratislava</city>
        <zip>85107</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona (Barcelona)</city>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Canarias</name>
      <address>
        <city>La Laguna (Tenerife)</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen De La Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Donosti</name>
      <address>
        <city>San Sebastián (Guipuzcoa)</city>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario De Santiago De Compostela</name>
      <address>
        <city>Santiago De Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Salud</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitetssjukhuset i Lund</name>
      <address>
        <city>Lund</city>
        <zip>SE-22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University HospitalSolna</name>
      <address>
        <city>Stockholm</city>
        <zip>SE 17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve-HUG</name>
      <address>
        <city>Genèva</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara University Medical Faculty Cebeci Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Medical School</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital Haematology Department</name>
      <address>
        <city>Belfast Northern Ireland</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kent and Canterbury Hospital</name>
      <address>
        <city>Canterbury/Kent</city>
        <zip>CT1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals Trust</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool University Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie Hospital NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Hospital Foundation Trust</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton (Surrey)</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Westbury-on-Trym/ Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
    <country>Slovenia</country>
  </removed_countries>
  <reference>
    <citation>Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.</citation>
    <PMID>27226434</PMID>
  </reference>
  <reference>
    <citation>Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.</citation>
    <PMID>28504846</PMID>
  </reference>
  <reference>
    <citation>Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.</citation>
    <PMID>30068263</PMID>
  </reference>
  <reference>
    <citation>Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.</citation>
    <PMID>27267105</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>November 25, 2020</results_first_submitted>
  <results_first_submitted_qc>December 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 10, 2022</results_first_posted>
  <last_update_submitted>December 10, 2021</last_update_submitted>
  <last_update_submitted_qc>December 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Relapsed Multiple Myeloma</keyword>
  <keyword>Relapsed and refractory Multiple Myeloma</keyword>
  <keyword>Pomalidomide</keyword>
  <keyword>Dexamethasone</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>Dexamethasone</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 30, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT01712789/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 6, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT01712789/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 112 sites: 4 in Austria, 7 in Belgium, 3 in Denmark, 1 in Estonia, 2 in Finland, 13 in France, 17 in Germany, 1 in Greece, 3 in Ireland, 15 in Italy, 5 in the Netherlands, 2 in Norway, 3 in Poland, 4 in Portugal, 1 in Slovakia, 15 in Spain, 2 in Sweden, 3 in Switzerland, 2 in Turkey, and 9 in the United Kingdom.</recruitment_details>
      <pre_assignment_details>Study participants had to have either refractory or relapsed and refractory disease, defined as documented disease progression during or within 60 days of completing their last myeloma therapy to be eligible to participate in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
          <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="682"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="676"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="682"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="504"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Transition to Commercial Treatment</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participants Did Not Receive Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
      <group_list>
        <group group_id="B1">
          <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
          <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="682"/>
          </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="65.4" spread="9.10"/>
                  </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="301"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="381"/>
                  </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="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="626"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="669"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 = Fully active, no restrictions</title>
                  <measurement_list>
                    <measurement group_id="B1" value="295"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 = Restricted activity but ambulatory</title>
                  <measurement_list>
                    <measurement group_id="B1" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 = Ambulatory and capable of all self-care</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 = Limited self-care</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 = Completely disabled</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time since diagnosis</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.15" spread="3.649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Beta 2 Microglobulin</title>
          <description>This test measures the amount of a protein called beta-2 microglobulin (B2M) in the blood.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.48" spread="4.713"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Light Chain Type</title>
          <description>Light chains are proteins made by plasma cells and make immunoglobulins (antibodies). Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein. There are two types of light chains: lambda and kappa light chains. A free light chains test measures the amount of lambda and kappa free light chains in the blood. If the amount of free light chains is higher or lower than normal, it can mean you have a disorder of the plasma cells.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Kappa</title>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lambda</title>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Serum Light chain Type Detected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test Not Performed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum Heavy Chain Type</title>
          <description>Immunoglobulins help protect the body against illness and infections. Immunoglobulins are formed when light chains link up with heavy chains, another type of protein.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Immunoglobulin A (IgA)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="145"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Immunoglobulin D (IgD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Immunoglobulin E (IgE)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Immunoglobulin G (IgG)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="388"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Immunoglobulin M (IgM)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No serum heavy chain type detected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Test not performed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Renal Function (Cockcroft Gault Creatinine Clearance)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 30 mL/min</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30 - &lt; 45 mL/min</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>45 - &lt; 60 mL/min</title>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60 - &lt; 80 mL/min</title>
                  <measurement_list>
                    <measurement group_id="B1" value="190"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 80 mL/min</title>
                  <measurement_list>
                    <measurement group_id="B1" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Corrected Serum Calcium</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.43" spread="0.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAE)</title>
        <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.&#xD;
A SAE = AE occurring at any dose that:&#xD;
Results in death;&#xD;
Is life-threatening&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant disability/incapacity&#xD;
Is a congenital anomaly/birth defect</description>
        <time_frame>From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.</time_frame>
        <population>The safety population includes all enrolled participants who received at least one dose of the IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAE)</title>
          <description>An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.&#xD;
A SAE = AE occurring at any dose that:&#xD;
Results in death;&#xD;
Is life-threatening&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant disability/incapacity&#xD;
Is a congenital anomaly/birth defect</description>
          <population>The safety population includes all enrolled participants who received at least one dose of the IP.</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="676"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥ TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE Related to Pomalidomide (POM)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE Related to LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE Related to Either POM or LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Grade (Gr) 3 or 4 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="606"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Gr 3 or 4 TEAE Related to (R/T) POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Gr 3 or 4 TEAE R/T LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Gr 3 or 4 TEAE R/T Either POM or LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Grade 5 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Grade 5 TEAE R/T POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Grade 5 TEAE R/T LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Grade 5 TEAE R/T either POM or LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE R/T POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE R/T LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE R/T Either POM or LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE Leading to (L/T)Stopping of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Serious TEAE L/T Stopping of LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 Serious TEAE L/T Stopping either POM or LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to Stopping of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to Stopping of LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to Stopping of Either POM or LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 Study Drug Related TEAE (L/T) Stopping POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 Study Drug Related TEAE L/T Stopping LD-Dex</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 Drug Related TEAE L/T Stopping LD-Dex or POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to Reduction (R/D) of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to R/D of LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to R/D of Either POM or LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Study Drug Related TEAE L/T to R/D of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Study Drug Related TEAE L/T to R/D of LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 StudyDrug Related TEAE L/T to R/D POM or LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to Interruption (I/R) of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to I/R of LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 TEAE L/T to I/R of either POM or LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Study Drug Related TEAE L/T to I/R of POM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 1 Study Drug Related TEAE L/T to I/R of LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 StudyDrug Related TEAE L/T to I/R POM or LD-DEX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response</title>
        <description>Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions</description>
        <time_frame>Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks</time_frame>
        <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response</title>
          <description>Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions</description>
          <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="682"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.4" lower_limit="29.9" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response</title>
        <description>Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.</description>
        <time_frame>Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks</time_frame>
        <population>Includes participants with a response (sCR, VGPR or PR).</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response</title>
          <description>Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.</description>
          <population>Includes participants with a response (sCR, VGPR or PR).</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="2" upper_limit="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan Meier Estimate of Duration of Response</title>
        <description>Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.</description>
        <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
        <population>Includes participants with a response (sCR, VGPR or PR).</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Duration of Response</title>
          <description>Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.</description>
          <population>Includes participants with a response (sCR, 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="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" lower_limit="6.48" upper_limit="8.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines</title>
        <description>Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.</description>
        <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
        <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines</title>
          <description>Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.</description>
          <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</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="682"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="3.91" upper_limit="4.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan Meier Estimate of Time to Progression</title>
        <description>Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).</description>
        <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
        <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Time to Progression</title>
          <description>Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).</description>
          <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</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="682"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="4.27" upper_limit="5.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan Meier Estimate of Overall Survival (OS)</title>
        <description>Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.</description>
        <time_frame>From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months</time_frame>
        <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Overall Survival (OS)</title>
          <description>Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.</description>
          <population>The intent to treat (ITT) population was defined as all enrolled participants (participants who received an interactive voice response system (IVRS) enrollment date) regardless of whether they received any investigational product (IP) or not.</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="682"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="10.65" upper_limit="13.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)</title>
        <description>Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.</description>
        <time_frame>Cycles 1, 2, 3, 4, 5, 6</time_frame>
        <population>Pharmacokinetic population&#xD;
Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)</title>
          <description>Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.</description>
          <population>Pharmacokinetic population&#xD;
Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide</population>
          <units>Liters/hour</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="476"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.02" lower_limit="5.67" upper_limit="6.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pomalidomide Exposure - Apparent Volume of Distribution (V/F)</title>
        <description>Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.</description>
        <time_frame>Cycles 1, 2, 3, 4, 5, 6</time_frame>
        <population>Pharmacokinetic population&#xD;
Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Pomalidomide Exposure - Apparent Volume of Distribution (V/F)</title>
          <description>Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.</description>
          <population>Pharmacokinetic population&#xD;
Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide</population>
          <units>Liters</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="476"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.10" lower_limit="63.57" upper_limit="89.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cytogenetic Analysis</title>
        <description>Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.</description>
        <time_frame>Study entry</time_frame>
        <population>Statistical analysis could not be performed due to high level of missing cytogenetic data as well as cytogenetic probe analysis being non- compliant with study requirements which lead to an inability to accurately identify specific cytogenetic abnormalities.</population>
        <group_list>
          <group group_id="O1">
            <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
            <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Cytogenetic Analysis</title>
          <description>Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.</description>
          <population>Statistical analysis could not be performed due to high level of missing cytogenetic data as well as cytogenetic probe analysis being non- compliant with study requirements which lead to an inability to accurately identify specific cytogenetic abnormalities.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality is reported from enrollment until the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months. Adverse events are reported from first dose of study drug up to 28 days after last dose; median duration of treatment was 21.4 weeks.</time_frame>
      <desc>Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)</title>
          <description>Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (&gt; 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</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="598" subjects_at_risk="682"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="448" subjects_at_risk="676"/>
              </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="15" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Heparin-induced thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperviscosity syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="676"/>
              </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="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardiac amyloidosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Nodal arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Exophthalmos</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastrointestinal amyloidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Intestinal infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Rectal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Euthanasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="676"/>
              </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="676"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gallbladder obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bacterial diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bursitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cerebral aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Citrobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Clostridial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Herpes zoster infection neurological</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Leishmaniasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Listeria sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Listeriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Meningitis pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Meningococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Osteomyelitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="117" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia respiratory syncytial viral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pseudomonal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory moniliasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Sinusitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Systemic candida</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Systemic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Febrile nonhaemolytic transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Ilium fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Perineal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Traumatic intracranial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin A increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Monoclonal immunoglobulin present</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </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="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperamylasaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </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="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bone lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Osteolysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Invasive breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Monoclonal gammopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Plasma cell leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Plasmacytoma</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the tongue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cauda equina syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>IIIrd nerve paresis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Lateral medullary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Motor dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Paraplegia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Ruptured cerebral aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </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="26" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Crush syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Renal vascular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Scrotal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </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="676"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="676"/>
              </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="676"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Social stay hospitalisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="646" subjects_at_risk="676"/>
              </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="327" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="382" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="236" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="163" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="155" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="197" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="178" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="676"/>
              </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="69" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="676"/>
              </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="42" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="676"/>
              </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="141" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="117" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="676"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="676"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="676"/>
              </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>Results from a center cannot be submitted for publication before results of multicenter study are published unless it is &gt; 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.</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/NCT01712789
org study id: CC-4047-MM-010
secondary id: 2012-001888-78
nct id: NCT01712789
lead sponsor: 
has dmc: Yes
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK
      and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients
      with refractory or relapsed and refractory multiple myeloma.

      The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment
      phase and a Follow-up phase which starts within 28 days of discontinuation from study
      treatment, every 3 months for up to 5 years.

      In addition, the collection of steady-state PK data from a large population will enable
      robust population PK and assess Pomalidomide exposure response analyses.

      The exploratory objectives of the study are to investigate potential markers predictive of
      POM response or resistance and pharmacodynamic markers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
time frame: From the first dose of study treatment up to 28 days following the last dose of study treatment. The median duration of treatment with pomalidomide and LD-dex was 21.4 weeks.
description: An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, regardless of etiology. Any worsening (i.e., any significant adverse change in the frequency or intensity of a pre- existing condition) was considered an AE. The severity of AEs were graded based on the symptoms according to version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events. Second primary malignancies were monitored as events of interest and considered as part of the assessment of AEs.
A SAE = AE occurring at any dose that:
Results in death;
Is life-threatening
Requires inpatient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
measure: Overall Response
time frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
description: Overall response rate (ORR) was defined as the percentage of participants with a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) according to the International Myeloma Working Group uniform response criteria (IMWG URC) assessed by the Investigator. Responses must have been confirmed at at least 2 consecutive assessments before the institution of any new therapy with no known evidence of progressive or new bone lesions
measure: Time to Response
time frame: Response was assessed at each treatment cycle and at treatment discontinuation; median duration of treatment with pomalidomide and LD-dex was 21.4 weeks
description: Time to response was defined as the time from treatment enrollment to the first documentation of response (sCR, CR, VGPR or PR) based on IMWG criteria.
measure: Kaplan Meier Estimate of Duration of Response
time frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description: Duration of response, calculated for responders only, was defined as time from the initial documented response (SCR, CR, VGPR or PR) to the first confirmed disease progression, or death if no disease progression was recorded. Participants without a documented progression were censored at the time of their last tumor assessment.
measure: Kaplan Meier Estimate of Progression Free Survival (PFS) According to the European Medicines Agency Guidelines
time frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description: Progression free survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until either PD or death (any cause). Participants without an event (either a documented PD or death) at the time of study end were censored at the time of their last documented disease assessment or at the IVRS enrollment date if no disease assessment was conducted.
measure: Kaplan Meier Estimate of Time to Progression
time frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description: Time to progression was calculated as the time from study enrollment until first recorded disease progression as determined by the site investigator based on the IMWG criteria, or until death due to progression. Participants not experiencing a documented progression were censored at the time of their last tumor assessment (or at the time of trial enrollment if no assessment was conducted).
measure: Kaplan Meier Estimate of Overall Survival (OS)
time frame: From enrollment to the end of follow-up; median time on follow-up was 10.9 (range 0 - 81) months
description: Overall survival was calculated as the time from study enrollment, defined as the IVRS enrollment date, until death due to any cause. Participants who did not have death data at the time of study end/analysis were censored at the time they were last known to be alive.
measure: Pomalidomide Exposure - Apparent (Oral) Clearance (CL/F)
time frame: Cycles 1, 2, 3, 4, 5, 6
description: Pharmacokinetic (PK) parameters are derived from pomalidomide concentration versus time data.
measure: Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
time frame: Cycles 1, 2, 3, 4, 5, 6
description: Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
measure: Cytogenetic Analysis
time frame: Study entry
description: Cytogenetic analysis was to be performed using fluorescence in situ hybridization (FISH) methodology at a local laboratory, to evaluate the relationship between cytogenetic profiles and the combination of POM and LD-DEX in terms of response and outcome.
arm group label: Pomalidomide plus Dexamethasone
arm group type: Experimental
description: Pomalidomide 4mg by mouth (PO) daily days 1 through 21 of a 28 day cycle and dexamethasone 40mg/day PO for those ≤75 years of age or 20mg/day for those greater than 75 years of age on Days 1, 8, 15 and 22 of a 28 day cycle.
intervention type: Drug
intervention name: Pomalidomide
description: Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
arm group label: Pomalidomide plus Dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
arm group label: Pomalidomide plus Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Teresa Peluso, MBBS, DCPSA
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Austria
country: Belgium
country: Denmark
country: Estonia
country: Finland
country: France
country: Germany
country: Greece
country: Ireland
country: Italy
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Slovakia
country: Spain
country: Sweden
country: Switzerland
country: Turkey
country: United Kingdom
country: Israel
country: Slovenia
citation: Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.
PMID: 27226434
citation: Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.
PMID: 28504846
citation: Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.
PMID: 30068263
citation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
PMID: 27267105
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Pomalidomide
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 