<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03033511</url>
  </required_header>
  <id_info>
    <org_study_id>M16-298</org_study_id>
    <secondary_id>2016-003503-64</secondary_id>
    <nct_id>NCT03033511</nct_id>
  </id_info>
  <brief_title>A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)</brief_title>
  <acronym>MERU</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and&#xD;
      multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy&#xD;
      following first-line platinum-based chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Independent Data Monitoring Committee recommendation&#xD;
  </why_stopped>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">November 20, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)</measure>
    <time_frame>Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.</time_frame>
    <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS in All Randomized Participants</measure>
    <time_frame>Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.</time_frame>
    <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time</measure>
    <time_frame>Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)</time_frame>
    <description>The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).&#xD;
The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">748</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Rovalpituzumab tesirine/dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo q6 wk; omitting every third cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for dexamethasone</intervention_name>
    <description>Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for rovalpituzumab tesirine</intervention_name>
    <description>Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rovalpituzumab tesirine</intervention_name>
    <description>Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle</description>
    <arm_group_label>Rovalpituzumab tesirine/dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.</description>
    <arm_group_label>Rovalpituzumab tesirine/dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed extensive-stage disease small cell lung&#xD;
             cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease&#xD;
             [SD], partial response [PR], or complete response [CR]) following completion of 4&#xD;
             cycles of first-line platinum-based therapy&#xD;
&#xD;
          -  Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day&#xD;
             1 of the fourth cycle of first-line platinum-based chemotherapy.&#xD;
&#xD;
          -  Participants with a history of central nervous system (CNS) metastases prior to the&#xD;
             initiation of first-line platinum-based chemotherapy must have received definitive&#xD;
             local treatment and have documentation of stable or improved CNS disease status&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1&#xD;
&#xD;
          -  Participants must have adequate bone marrow, renal and hepatic function&#xD;
&#xD;
          -  Availability of archived or representative tumor material for assessment of DLL3&#xD;
             expression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint&#xD;
             inhibitors, other monoclonal antibodies, antibody-drug conjugates,&#xD;
             radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other&#xD;
             anti-cancer therapy than that described in inclusion criteria for SCLC.&#xD;
&#xD;
          -  Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative&#xD;
             radiotherapy to a radiographically documented non-progressing lesion for symptom&#xD;
             control, or pre-planned radiotherapy for CNS metastases present prior to start of&#xD;
             first-line therapy and non-progressing) after last dose of first-line chemotherapy.&#xD;
&#xD;
          -  Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based&#xD;
             drug, prior participation in a rovalpituzumab tesirine clinical trial, or known&#xD;
             hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient&#xD;
             contained in the drug formulation.&#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>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clearview Cancer Institute /ID# 156699</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Alabama /ID# 160975</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604-3302</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group /ID# 156722</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703-4005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Cancer Care /ID# 159207</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ucsd /Id# 157764</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Hem-Oncology Med Group /ID# 156717</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palo Alto Veterans Institute for Research /ID# 203695</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304-1207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Jude Hospital dba St Joseph /ID# 156526</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icri /Id# 157765</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Lone Tree /ID# 159331</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health Service /ID# 159212</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital /ID# 156716</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida - Archer /ID# 155799</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Cancer Institute /ID# 156673</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021-5421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Cancer Institute /ID# 164052</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021-5421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Specialists of North Florida - Southpoint /ID# 156595</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Cancer Center /ID# 201894</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Regional Medical /ID# 163064</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Mountain States Tumor Institute - Boise /ID# 156691</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem - Evanston Hospital /ID# 156664</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hosp /ID# 156685</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Goshen Center for Cancer Care /ID# 156682</name>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <zip>46526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ashland-Bellefonte Cancer Ctr /ID# 202901</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville /ID# 156683</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation /ID# 159136</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70836-6455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System /ID# 156712</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester /ID# 160181</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Division, Inc. /ID# 163530</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic /ID# 201788</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101-0733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Hematology Oncology /ID# 156534</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center at Cooper - Camden /ID# 156681</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center /ID# 201845</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health - Monter Cancer Center /ID# 159252</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Med Mt. Sinai /ID# 159210</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital /ID# 159272</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center /ID# 156706</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710-3000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health /ID# 156689</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health /ID# 163612</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Carolina University /ID# 159264</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research /ID# 156667</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente, NW /ID# 201793</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University /ID# 156719</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107-4414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Pittsburgh HealthcareSystem /ID# 159284</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital /ID# 160834</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute-Chattanooga /ID# 202933</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404-1108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thompson Cancer Survival Ctr /ID# 202460</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Nashville Centennial /ID# 161168</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ Medical Ctr Brackenridge /ID# 155798</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health and Hosp Syste /ID# 170933</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center /ID# 157848</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-7208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital - Scurlock Tower /ID# 202323</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Associates /ID# 156715</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia Univ School Med /ID# 156687</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coffs Harbour Hospital /ID# 158880</name>
      <address>
        <city>Coffs Harbour</city>
        <state>New South Wales</state>
        <zip>2450</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital /ID# 158884</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Private Hospital /ID# 203506</name>
      <address>
        <city>Lambton Heights</city>
        <state>New South Wales</state>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital /ID# 158881</name>
      <address>
        <city>Saint Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary North Adelaide Hospita /ID# 161701</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital /ID# 161700</name>
      <address>
        <city>St Albans</city>
        <state>Victoria</state>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affinity Clinical Research Ser /ID# 158887</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Nord - Klinik Floridsdorf /ID# 201768</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1210</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-Univ. Klinikum Graz /ID# 159563</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salzburger Landeskliniken (SALK) /ID# 201779</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bobruysk Interdistrict Onco. /ID# 169393</name>
      <address>
        <city>Bobruisk</city>
        <zip>213825</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383</name>
      <address>
        <city>Lesnoy</city>
        <zip>223040</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mogilev Reg Clin Oncology Dis /ID# 159384</name>
      <address>
        <city>Mogilev</city>
        <zip>212018</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Pierre /ID# 159009</name>
      <address>
        <city>Bruxelles</city>
        <state>Bruxelles-Capitale</state>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi /ID# 159006</name>
      <address>
        <city>Charleroi</city>
        <state>Hainaut</state>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim /ID# 159007</name>
      <address>
        <city>Antwerp</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Jolimont /ID# 159005</name>
      <address>
        <city>Haine Saint Paul</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Charleroi (Vesale) /ID# 159008</name>
      <address>
        <city>Montigny-le-tilleul</city>
        <zip>6110</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Evangelico de Cachoei /ID# 159657</name>
      <address>
        <city>Cachoeiro de Itapemirim</city>
        <state>Espirito Santo</state>
        <zip>29308-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Norte Rio Grandense Cont. /ID# 159011</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <zip>59075-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013</name>
      <address>
        <city>Ijuí</city>
        <state>Rio Grande Do Sul</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661</name>
      <address>
        <city>Passo Fundo</city>
        <state>Rio Grande Do Sul</state>
        <zip>99010-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Lucas da PUCRS /ID# 159662</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659</name>
      <address>
        <city>Sao Jose Do Rio Preto</city>
        <state>Sao Paulo</state>
        <zip>15090-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20231-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Tsaritsa Joanna - ISUL /ID# 159638</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sv. Ivan Rilski /ID# 159639</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency /ID# 163721</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brampton Civic Hospital /ID# 204425</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R.S. McLaughlin Durham Regional /ID# 170870</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret /ID# 170868</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Regional Cancer Centre /ID# 170869</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 2X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iucpq-Ul /Id# 159530</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Provincial Cancer Hospital /ID# 204864</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital /Id# 203638</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital /ID# 202886</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hosptial /ID# 204060</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <zip>830000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yunnan Cancer Hospital /ID# 204911</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650118</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer hospital /ID# 204640</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital /ID# 206802</name>
      <address>
        <city>Jianggan Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310018</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital /ID# 205183</name>
      <address>
        <city>Nanjing</city>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4th Military Medical Universit /ID# 203986</name>
      <address>
        <city>Xi'an</city>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital /ID# 203983</name>
      <address>
        <city>Zhengzhou Henan</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital /ID# 204636</name>
      <address>
        <city>Zhengzhou Henan</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Sestre milosrdnice /ID# 159090</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika za plucne bolesti Jordanovac /ID# 159505</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Rijeka /ID# 159504</name>
      <address>
        <city>Rijeka</city>
        <state>Primorsko-goranska Zupanija</state>
        <zip>51000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomayerova nemocnice /ID# 159062</name>
      <address>
        <city>Prague</city>
        <state>Praha 4</state>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Rudolfa a Stefanie /ID# 159655</name>
      <address>
        <city>Benesov</city>
        <zip>256 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Horovice a.s. /ID# 161186</name>
      <address>
        <city>Horovice</city>
        <zip>268 31</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitkovicka nemocnice a. s. /ID# 161187</name>
      <address>
        <city>Ostrava</city>
        <zip>703 84</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FN Plzen /ID# 204097</name>
      <address>
        <city>Plzen</city>
        <zip>323 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oblastni Nemocnice Pribram /ID# 159654</name>
      <address>
        <city>Pribram</city>
        <zip>262 04</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet /ID# 158055</name>
      <address>
        <city>Copenhagen Ø</city>
        <state>Hovedstaden</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev Hospital /ID# 158053</name>
      <address>
        <city>Herlev</city>
        <state>Hovedstaden</state>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital /ID# 203737</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitets Hospital /ID# 158054</name>
      <address>
        <city>Odense C</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tallinn Central Hospital /ID# 160019</name>
      <address>
        <city>Tallinn</city>
        <zip>10138</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonian Medical Centre /ID# 159779</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Docrates Cancer Center /ID# 159591</name>
      <address>
        <city>Helsinki</city>
        <zip>00180</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Nord /ID# 160543</name>
      <address>
        <city>Marseille</city>
        <state>Bouches-du-Rhone</state>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Haut-Lévêque /ID# 160547</name>
      <address>
        <city>Pessac CEDEX</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Calmette /ID# 202706</name>
      <address>
        <city>Lille</city>
        <state>Hauts-de-France</state>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie /ID# 207514</name>
      <address>
        <city>Paris CEDEX 05</city>
        <state>Ile-de-France</state>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard /ID# 160550</name>
      <address>
        <city>Lyon CEDEX 08</city>
        <state>Rhone</state>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosp Intercommunal de Creteil /ID# 162686</name>
      <address>
        <city>Creteil</city>
        <state>Val-de-Marne</state>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon /ID# 160541</name>
      <address>
        <city>Paris</city>
        <zip>75970</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pontchaillou /ID# 160544</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvel Hopital Civil (NHC) /ID# 204427</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Larrey /ID# 204290</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH Martha-Maria Halle Dolau /ID# 158794</name>
      <address>
        <city>Halle (Saale)</city>
        <state>Sachsen-Anhalt</state>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelische Lungenklinik Berl /ID# 158935</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Fachkliniken M. Gaut /ID# 158789</name>
      <address>
        <city>Gauting</city>
        <zip>82131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg gGmbH /ID# 158871</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungenklinik Hemer /ID# 158790</name>
      <address>
        <city>Hemer</city>
        <zip>58675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Kassel /ID# 158786</name>
      <address>
        <city>Kassel</city>
        <zip>34125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Loewenstein GmbH /ID# 158870</name>
      <address>
        <city>Löwenstein</city>
        <zip>74245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachkliniken Wangen /ID# 160779</name>
      <address>
        <city>Wangen</city>
        <zip>88239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan General Hospital /ID# 202422</name>
      <address>
        <city>Cholargos</city>
        <state>Attiki</state>
        <zip>15562</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metropolitan Hospital /ID# 159157</name>
      <address>
        <city>Athens</city>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Heraklion PA.G.N.I /ID# 202409</name>
      <address>
        <city>Heraklion</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Ioannin /ID# 159158</name>
      <address>
        <city>Ioannina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Oncological Hospital /ID# 159159</name>
      <address>
        <city>Nea Kifisia</city>
        <zip>14564</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedica General Clinic /ID# 159156</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital /ID# 159565</name>
      <address>
        <city>Kowloon</city>
        <zip>852</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital /ID# 162810</name>
      <address>
        <city>Lai Chi Kok</city>
        <zip>999077</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tuen Mun Hospital /ID# 162435</name>
      <address>
        <city>Tuen Mun</city>
        <zip>999077</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Koranyi Pulmonologiai Intezet /ID# 158953</name>
      <address>
        <city>Budapest XII</city>
        <state>Budapest</state>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466</name>
      <address>
        <city>Nyiregyhaza</city>
        <state>Szabolcs-Szatmar-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem /ID# 158955</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Csongrad Megyei Mellkasi Beteg /ID# 158952</name>
      <address>
        <city>Deszk</city>
        <zip>6772</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James's Hospital /ID# 159712</name>
      <address>
        <city>Dublin 8</city>
        <state>Dublin</state>
        <zip>D08 E9P6</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital /ID# 159715</name>
      <address>
        <city>Cork</city>
        <zip>T12 E8YV</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hosp /ID# 161678</name>
      <address>
        <city>Dublin</city>
        <zip>D04 T6F4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital /ID# 159711</name>
      <address>
        <city>Dublin</city>
        <zip>D09 XR63</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Limerick /ID# 159714</name>
      <address>
        <city>Limerick</city>
        <zip>V94F858</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Waterford /ID# 159713</name>
      <address>
        <city>Waterford</city>
        <zip>X91 ER8E</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center /ID# 159764</name>
      <address>
        <city>Petakh Tikva</city>
        <state>Tel-Aviv</state>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 161467</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center /ID# 159762</name>
      <address>
        <city>Be'er Sheva</city>
        <zip>84101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 201883</name>
      <address>
        <city>Be'er Ya'akov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 202336</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah /ID# 159763</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center /ID# 159761</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center /ID# 159760</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5239424</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898</name>
      <address>
        <city>Meldola</city>
        <state>Emilia-Romagna</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Bio-Medico /ID# 160874</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AUSL 8 Arezzo Ospedale San Don /ID# 160897</name>
      <address>
        <city>Arezzo</city>
        <zip>52100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. San Luigi Gonzaga /ID# 158916</name>
      <address>
        <city>Orbassano</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria delle Cro /ID# 158911</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IFO Istituto Nazionale Tumori /ID# 158912</name>
      <address>
        <city>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital /ID# 164976</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East /ID# 165721</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 165722</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital /ID# 164595</name>
      <address>
        <city>Kurume-shi</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital /ID# 165127</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center /ID# 165015</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital /ID# 165746</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>2360004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Okayama Hospital /ID# 165157</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>7008607</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital /ID# 165054</name>
      <address>
        <city>Hirakata-shi</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital /ID# 166395</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center /ID# 166272</name>
      <address>
        <city>Sunto-gun</city>
        <state>Shizuoka</state>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital /ID# 166105</name>
      <address>
        <city>Tokushima-shi</city>
        <state>Tokushima</state>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital /ID# 166547</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital /ID# 165575</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University /ID# 165946</name>
      <address>
        <city>Wakayama-shi</city>
        <state>Wakayama</state>
        <zip>641-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center /ID# 165138</name>
      <address>
        <city>Akashi</city>
        <zip>673-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Himeji Medical Center /ID# 165899</name>
      <address>
        <city>Himeji</city>
        <zip>670-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsusaka City Hospital /ID# 166156</name>
      <address>
        <city>Matsusaka-shi MIE</city>
        <zip>515-8544</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital /ID# 165714</name>
      <address>
        <city>Osaka</city>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Cancer Center /ID# 165236</name>
      <address>
        <city>Sapporo</city>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital /ID# 166491</name>
      <address>
        <city>Sendai</city>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center /ID# 165814</name>
      <address>
        <city>Yokohama</city>
        <zip>241-0815</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital /ID# 159305</name>
      <address>
        <city>Busan</city>
        <state>Busan Gwang Yeogsi</state>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical center CHA University /ID# 161281</name>
      <address>
        <city>Seongnam si</city>
        <state>Gyeonggido</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital /ID# 159301</name>
      <address>
        <city>Daegu</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 159304</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital /ID# 159302</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University /ID# 159300</name>
      <address>
        <city>Cheongju-si</city>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital /ID# 159297</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center /ID# 159299</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical /ID# 158715</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga East Clinical University /ID# 158716</name>
      <address>
        <city>Riga</city>
        <zip>LV-1079</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016</name>
      <address>
        <city>Kovno</city>
        <state>Kaunas</state>
        <zip>50009</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klaipeda University Hospital /ID# 160018</name>
      <address>
        <city>Klaipeda</city>
        <zip>LT-92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute /ID# 160017</name>
      <address>
        <city>Vilnius</city>
        <zip>08660</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Clinica Chapultepec /ID# 160965</name>
      <address>
        <city>Morelia</city>
        <state>Michoacan</state>
        <zip>58260</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Pharma professional Ser /ID# 160734</name>
      <address>
        <city>Ciudad de México</city>
        <zip>03810</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meander Medisch Centrum /ID# 159064</name>
      <address>
        <city>Amersfoort</city>
        <zip>3813 TZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate /ID# 159063</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Ziekenhuis /ID# 159065</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis /ID# 158082</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum /ID# 161669</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis /ID# 158081</name>
      <address>
        <city>S Hertogenbosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht /ID# 158083</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akershus universitetssykehus /ID# 201682</name>
      <address>
        <city>Nordbyhagen</city>
        <state>Akershus</state>
        <zip>1474</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drammen Sykehus /ID# 159572</name>
      <address>
        <city>Drammen</city>
        <state>Buskerud</state>
        <zip>3004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital /ID# 159573</name>
      <address>
        <city>Bergen</city>
        <state>Hordaland</state>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Olavs Hospital HF /ID# 163110</name>
      <address>
        <city>Trondheim</city>
        <state>Sor-Trondelag</state>
        <zip>7006</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiumhospitalet, OUS /ID# 159574</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stavanger Universitetssykehus /ID# 159575</name>
      <address>
        <city>Stavanger</city>
        <zip>4011</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604</name>
      <address>
        <city>Rzeszów</city>
        <state>Podkarpackie</state>
        <zip>35-021</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalisty /ID# 159603</name>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie Sp. z o.o /ID# 159605</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Norte, EPE /ID# 159957</name>
      <address>
        <city>Lisbon</city>
        <state>Lisboa</state>
        <zip>1769-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO Lisboa FG, EPE /ID# 159949</name>
      <address>
        <city>Lisboa</city>
        <zip>1099-023</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz, SA /ID# 159954</name>
      <address>
        <city>Lisbon</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade Local Saude Matosinhos /ID# 159950</name>
      <address>
        <city>Matosinhos</city>
        <zip>4464-513</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto EPE /ID# 203582</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Porto /ID# 159955</name>
      <address>
        <city>Porto</city>
        <zip>4100-180</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO Porto FG, EPE /ID# 159956</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Medical Research Cntr /ID# 169885</name>
      <address>
        <city>Moscow</city>
        <state>Moskovskaya Oblast</state>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk clinical oncology /ID# 159367</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaluga Regional Clinical Oncol /ID# 160180</name>
      <address>
        <city>Kaluga</city>
        <zip>284007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Onco Dispensary /ID# 159365</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMI Euromedservice /ID# 159369</name>
      <address>
        <city>Pushkin</city>
        <zip>196603</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Novaya Clinica /ID# 205523</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357532</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OOO Centre of Palliative Medicine De Vita /ID# 206855</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197343</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogarev Mordovia State Univ /ID# 205742</name>
      <address>
        <city>Saransk</city>
        <zip>430005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smolensk Regional Onc Clin Dis /ID# 159372</name>
      <address>
        <city>Smolensk</city>
        <zip>214009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC BioEq Ltd. /ID# 159368</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197342</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N. Petrov Research Inst Onc /ID# 159370</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Serbia /ID# 160902</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clin Hosp Ctr Bezanijska Kosa /ID# 160903</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Nis /ID# 160905</name>
      <address>
        <city>NIS</city>
        <state>Nisavski Okrug</state>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut za onkologiju i radio /ID# 160904</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute For Pulmonary Diseas /ID# 164250</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancercare Langenhoven Drive Oncology Centre /ID# 159126</name>
      <address>
        <city>Port Elizabeth</city>
        <state>Eastern Cape</state>
        <zip>6045</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Potter Oncology Centre /ID# 158877</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Centre /ID# 158872</name>
      <address>
        <city>Durban</city>
        <state>Kwazulu-Natal</state>
        <zip>4091</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Town Oncology Trials /ID# 201311</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancercare Outeniqua Oncology Unit /ID# 200689</name>
      <address>
        <city>George</city>
        <state>Western Cape</state>
        <zip>6530</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Teresa Herrera - CHUAC /ID# 164368</name>
      <address>
        <city>A Coruña</city>
        <state>A Coruna</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional de Malaga /ID# 164371</name>
      <address>
        <city>Málaga</city>
        <state>Malaga</state>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc de Salut del Mar /ID# 159690</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron /ID# 159708</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario San Carlos /ID# 159706</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz /ID# 159693</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz /ID# 159692</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa /ID# 159709</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralsjukhuset, Karlstad /ID# 163451</name>
      <address>
        <city>Karlstad</city>
        <state>Varmlands Lan</state>
        <zip>651 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska US Gbg /ID# 159524</name>
      <address>
        <city>Göteborg</city>
        <state>Vastra Gotalands Lan</state>
        <zip>413 46</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Linkoping /ID# 159046</name>
      <address>
        <city>Linkoping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Univ Sjukhuset /ID# 159649</name>
      <address>
        <city>Solna</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital /ID# 159052</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve /ID# 160603</name>
      <address>
        <city>Genève</city>
        <state>Geneve</state>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen /ID# 160604</name>
      <address>
        <city>St. Gallen</city>
        <state>Sankt Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsspital Basel /ID# 160605</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital /ID# 160607</name>
      <address>
        <city>Luzern</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Winterthur /ID# 161379</name>
      <address>
        <city>Winterthur</city>
        <zip>8401</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hosp /ID# 158981</name>
      <address>
        <city>Taichung City</city>
        <state>Taichung</state>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital /ID# 158799</name>
      <address>
        <city>Tainan City</city>
        <state>Tainan</state>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan Univ Hosp /ID# 159049</name>
      <address>
        <city>Taipei City</city>
        <state>Taipei</state>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital /ID# 158980</name>
      <address>
        <city>Taipei City</city>
        <state>Taipei</state>
        <zip>11490</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dalin Tzu Chi General Hospital /ID# 158983</name>
      <address>
        <city>Dalin Township</city>
        <zip>622</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80708</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hosp /ID# 159047</name>
      <address>
        <city>Taichung City</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hosp /ID# 203699</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty /ID# 159242</name>
      <address>
        <city>Altindağ</city>
        <state>Ankara</state>
        <zip>06250</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes University Medical Fac /ID# 202269</name>
      <address>
        <city>Melikgazi</city>
        <state>Kayseri</state>
        <zip>38030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ataturk Gogus Hastalikl /ID# 159556</name>
      <address>
        <city>Ankara</city>
        <zip>06280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akdeniz Universitesi Tip Fakul /ID# 160791</name>
      <address>
        <city>Antalya</city>
        <zip>07059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezmi alem Vakif Universitesi /ID# 202267</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Medeniyet Universites /ID# 200126</name>
      <address>
        <city>Istanbul</city>
        <zip>34722</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty /ID# 159243</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Suat Seren Gogus Has /ID# 159244</name>
      <address>
        <city>Izmir</city>
        <zip>35110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu University /ID# 159245</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131</name>
      <address>
        <city>Zaporizhzhia</city>
        <state>Zaporizka Oblast</state>
        <zip>69040</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal institution Multifie /ID# 159130</name>
      <address>
        <city>Dnipro</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Center of Oncology /ID# 159132</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PE PMC Acinus, Medical and Diagnostic Center /ID# 165543</name>
      <address>
        <city>Kropyvnytskyi</city>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volyn Regional Medical Oncology Centre /ID# 159133</name>
      <address>
        <city>Lutsk</city>
        <zip>43018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Nonprofit Enterprise &quot;Central City Clinical Hospital&quot; of Uzhhorod City /ID# 159865</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheltenham General Hospital /ID# 169096</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloucestershire</state>
        <zip>GL53 7AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Medical Centre /ID# 162899</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Bournemouth Hospital /ID# 159039</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colchester General Hospital /ID# 159042</name>
      <address>
        <city>Colchester</city>
        <zip>CO4 5JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hereford County Hospital /ID# 159038</name>
      <address>
        <city>Hereford</city>
        <zip>HR1 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's Healthcare NHS /ID# 202416</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charing Cross Hospital /ID# 161399</name>
      <address>
        <city>London</city>
        <zip>W6 8RF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maidstone Hospital /ID# 159043</name>
      <address>
        <city>Maidstone</city>
        <zip>ME16 9QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christie NHS Foundation Trust /ID# 159037</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torbay Hospital - So Devon HC /ID# 159041</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>November 11, 2020</results_first_submitted>
  <results_first_submitted_qc>December 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2020</results_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extensive-Stage Small Cell Lung Cancer (ED SCLC)</keyword>
  <keyword>Cancer</keyword>
  <keyword>Platinum-Based Chemotherapy</keyword>
  <keyword>Rovalpituzumab tesirine</keyword>
  <keyword>first-line chemotherapy</keyword>
  <keyword>Small Cell Lung Cancer (SCLC)</keyword>
  <keyword>Delta-like protein 3 (DLL3)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
    <mesh_term>Rovalpituzumab tesirine</mesh_term>
    <mesh_term>Immunoconjugates</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <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>March 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03033511/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>May 29, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03033511/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03033511/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo every 6 weeks (q6 wk); omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
        <group group_id="P2">
          <title>Rovalpituzumab Tesirine/Dexamethasone</title>
          <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="376"/>
                <participants group_id="P2" count="372"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="376"/>
                <participants group_id="P2" count="372"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo every 6 weeks (q6 wk); omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
        <group group_id="B2">
          <title>Rovalpituzumab Tesirine/Dexamethasone</title>
          <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="376"/>
            <count group_id="B2" value="372"/>
            <count group_id="B3" value="748"/>
          </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="63.8" spread="8.20"/>
                    <measurement group_id="B2" value="64.1" spread="8.40"/>
                    <measurement group_id="B3" value="63.9" spread="8.29"/>
                  </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="137"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="258"/>
                    <measurement group_id="B3" value="497"/>
                  </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>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="356"/>
                    <measurement group_id="B2" value="355"/>
                    <measurement group_id="B3" value="711"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" 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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="301"/>
                    <measurement group_id="B2" value="314"/>
                    <measurement group_id="B3" value="615"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple Races</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)</title>
        <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
        <time_frame>Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.</time_frame>
        <population>DLL3 High Set: all randomized participants with extensive-stage small cell lung cancer with delta-like protein 3 high expression in tumor (DLL3high), defined as ≥ 75% tumor cells staining positive according to the VENTANA DLL3 [SP347] immunohistochemistry [IHC] assay.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo every 6 weeks (q6 wk); omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
          <group group_id="O2">
            <title>Rovalpituzumab Tesirine/Dexamethasone</title>
            <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)</title>
          <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
          <population>DLL3 High Set: all randomized participants with extensive-stage small cell lung cancer with delta-like protein 3 high expression in tumor (DLL3high), defined as ≥ 75% tumor cells staining positive according to the VENTANA DLL3 [SP347] immunohistochemistry [IHC] assay.</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="240"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.79" lower_limit="8.38" upper_limit="10.87"/>
                    <measurement group_id="O2" value="8.48" lower_limit="7.26" upper_limit="10.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.537</p_value>
            <p_value_desc>stratified log-rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>OS in All Randomized Participants</title>
        <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
        <time_frame>Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.</time_frame>
        <population>Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo every 6 weeks (q6 wk); omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
          <group group_id="O2">
            <title>Rovalpituzumab Tesirine/Dexamethasone</title>
            <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
        </group_list>
        <measure>
          <title>OS in All Randomized Participants</title>
          <description>OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.</description>
          <population>Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received.</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="376"/>
                <count group_id="O2" value="372"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.89" lower_limit="8.61" upper_limit="11.01"/>
                    <measurement group_id="O2" value="8.80" lower_limit="7.95" upper_limit="9.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.237</p_value>
            <p_value_desc>stratified log-rank test</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time</title>
        <description>The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).&#xD;
The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.</description>
        <time_frame>Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)</time_frame>
        <population>Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. Participants with an assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo every 6 weeks (q6 wk); omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
          <group group_id="O2">
            <title>Rovalpituzumab Tesirine/Dexamethasone</title>
            <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time</title>
          <description>The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).&#xD;
The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.</description>
          <population>Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. Participants with an assessment at given time point.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="376"/>
                <count group_id="O2" value="372"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.97" spread="1.00"/>
                    <measurement group_id="O2" value="-4.34" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.70" spread="1.67"/>
                    <measurement group_id="O2" value="-12.13" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.15" spread="4.02"/>
                    <measurement group_id="O2" value="-19.52" spread="4.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.95" spread="7.32"/>
                    <measurement group_id="O2" value="-19.39" spread="6.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.33" spread="4.22"/>
                    <measurement group_id="O2" value="-16.67" spread="6.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.33" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="-13.33" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.67" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="-3.33" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.67" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="-63.33" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.67" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 66</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 72</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 78</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                    <measurement group_id="O2" value="0.00" spread="NA">Statistical model did not support SE estimation for a sample set that was &lt; 5 participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week Final Visit</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="298"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.14" spread="1.02"/>
                    <measurement group_id="O2" value="-13.31" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Least Squares (LS) Mean of Difference</param_type>
            <param_value>-0.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.08</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-10.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.58</ci_lower_limit>
            <ci_upper_limit>-6.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 18</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-27.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.19</ci_lower_limit>
            <ci_upper_limit>-9.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 24</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-18.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.99</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.28</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 30</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-22.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.27</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-42.63</ci_lower_limit>
            <ci_upper_limit>-1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 36</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>0.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 42</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>3.33</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 48</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-56.67</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 60</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>0.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 66</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-0.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Week 78</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>0.00</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change at Final Visit</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>LS Mean of Difference</param_type>
            <param_value>-9.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.16</ci_lower_limit>
            <ci_upper_limit>-6.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.</time_frame>
      <desc>All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo q6 wk; omitting every third cycle&#xD;
Placebo for rovalpituzumab tesirine: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
        <group group_id="E2">
          <title>Rovalpituzumab Tesirine/Dexamethasone</title>
          <description>Rovalpituzumab tesirine/dexamethasone q6 wk; omitting every third cycle&#xD;
Rovalpituzumab tesirine: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle&#xD;
Dexamethasone: Dexamethasone 8 mg administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.1</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="201" subjects_at_risk="376"/>
                <counts group_id="E2" subjects_affected="226" subjects_at_risk="372"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="373"/>
                <counts group_id="E2" subjects_affected="157" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PANCYTOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RIGHT VENTRICULAR FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTHYROIDISM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>ANGLE CLOSURE GLAUCOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>EYELID OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PERIORBITAL SWELLING</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VISUAL IMPAIRMENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL ADHESIONS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ASCITES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>COLITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DUODENAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DUODENAL ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GASTRIC PERFORATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PANCREATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>STOMATITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>UPPER GASTROINTESTINAL HAEMORRHAGE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DEATH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DISEASE PROGRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>EUTHANASIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FACE OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GENERAL PHYSICAL HEALTH DETERIORATION</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="373"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GENERALISED OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOTHERMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MULTIPLE ORGAN DYSFUNCTION SYNDROME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SEROSITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SUDDEN DEATH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SWELLING FACE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS ACUTE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DRUG-INDUCED LIVER INJURY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEPATIC FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEPATIC FUNCTION ABNORMAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEPATITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEPATOTOXICITY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPERBILIRUBINAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>JAUNDICE CHOLESTATIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LIVER DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BILIARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CAMPYLOBACTER GASTROENTERITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CORONA VIRUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CYTOMEGALOVIRUS CHORIORETINITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ERYSIPELAS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GANGRENE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HAEMOPHILUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LUNG ABSCESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METAPNEUMOVIRUS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PNEUMOCYSTIS JIROVECII PNEUMONIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="373"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PNEUMONIA BACTERIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PNEUMONIA PSEUDOMONAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PSEUDOMONAS INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SEPTIC SHOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SUBCUTANEOUS ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HIP FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PELVIC FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RADIATION PNEUMONITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BLOOD CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BLOOD URIC ACID INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>C-REACTIVE PROTEIN INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEPATIC ENZYME INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>OXYGEN SATURATION DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PANCREATIC ENZYMES INCREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>CACHEXIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIABETES MELLITUS INADEQUATE CONTROL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FAILURE TO THRIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPERCALCAEMIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="373"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOPROTEINAEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FIBROMYALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MUSCULAR WEAKNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>OSTEOLYSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA GASTRIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>INFECTED NEOPLASM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LUNG NEOPLASM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MALIGNANT NEOPLASM PROGRESSION</sub_title>
                <counts group_id="E1" events="25" subjects_affected="21" subjects_at_risk="373"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METASTASES TO CENTRAL NERVOUS SYSTEM</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="373"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METASTASES TO LIVER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METASTASES TO MENINGES</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METASTATIC NEOPLASM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NEOPLASM PROGRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NEUROENDOCRINE CARCINOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SINONASAL PAPILLOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SMALL CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SMALL CELL LUNG CANCER METASTATIC</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>TUMOUR PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>BRAIN OEDEMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>COGNITIVE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSMETRIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>EPILEPSY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FACIAL PARESIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGE INTRACRANIAL</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPERAESTHESIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOAESTHESIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>METABOLIC ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NERVOUS SYSTEM DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PARAPLEGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SPINAL CORD COMPRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VOCAL CORD PARALYSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSIONAL STATE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DELIRIUM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>MENTAL STATUS CHANGES</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY DISTRESS SYNDROME</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BRONCHIAL OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="373"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>LUNG DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="373"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PULMONARY ARTERY THROMBOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DERMATITIS BULLOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PHOTOSENSITIVITY REACTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RASH ERYTHEMATOUS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SKIN EXFOLIATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>JUGULAR VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SHOCK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SUPERIOR VENA CAVA SYNDROME</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="373"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VASCULAR COMPRESSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="373"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VENA CAVA THROMBOSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="373"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.1</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="248" subjects_at_risk="373"/>
                <counts group_id="E2" subjects_affected="315" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" events="18" subjects_affected="11" subjects_at_risk="373"/>
                <counts group_id="E2" events="51" subjects_affected="45" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NEUTROPENIA</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="373"/>
                <counts group_id="E2" events="37" subjects_affected="31" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" events="19" subjects_affected="14" subjects_at_risk="373"/>
                <counts group_id="E2" events="79" subjects_affected="61" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>PERICARDIAL EFFUSION</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="373"/>
                <counts group_id="E2" events="63" subjects_affected="58" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="373"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="37" subjects_affected="35" subjects_at_risk="373"/>
                <counts group_id="E2" events="57" subjects_affected="48" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" events="39" subjects_affected="35" subjects_at_risk="373"/>
                <counts group_id="E2" events="35" subjects_affected="30" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="373"/>
                <counts group_id="E2" events="23" subjects_affected="20" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="56" subjects_affected="51" subjects_at_risk="373"/>
                <counts group_id="E2" events="86" subjects_affected="77" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="40" subjects_affected="35" subjects_at_risk="373"/>
                <counts group_id="E2" events="41" subjects_affected="35" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" events="27" subjects_affected="25" subjects_at_risk="373"/>
                <counts group_id="E2" events="48" subjects_affected="34" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FACE OEDEMA</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="373"/>
                <counts group_id="E2" events="48" subjects_affected="41" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="66" subjects_affected="60" subjects_at_risk="373"/>
                <counts group_id="E2" events="112" subjects_affected="91" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="373"/>
                <counts group_id="E2" events="134" subjects_affected="93" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="373"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="373"/>
                <counts group_id="E2" events="45" subjects_affected="39" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="373"/>
                <counts group_id="E2" events="59" subjects_affected="48" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BLOOD ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="373"/>
                <counts group_id="E2" events="44" subjects_affected="29" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>GAMMA-GLUTAMYLTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="373"/>
                <counts group_id="E2" events="21" subjects_affected="19" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>WEIGHT DECREASED</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="373"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" events="55" subjects_affected="49" subjects_at_risk="373"/>
                <counts group_id="E2" events="115" subjects_affected="95" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="373"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINAEMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="373"/>
                <counts group_id="E2" events="41" subjects_affected="32" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="373"/>
                <counts group_id="E2" events="34" subjects_affected="27" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="373"/>
                <counts group_id="E2" events="33" subjects_affected="30" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="373"/>
                <counts group_id="E2" events="23" subjects_affected="22" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="373"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="373"/>
                <counts group_id="E2" events="39" subjects_affected="31" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="373"/>
                <counts group_id="E2" events="33" subjects_affected="33" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="47" subjects_affected="43" subjects_at_risk="373"/>
                <counts group_id="E2" events="69" subjects_affected="56" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" events="41" subjects_affected="39" subjects_at_risk="373"/>
                <counts group_id="E2" events="83" subjects_affected="67" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="373"/>
                <counts group_id="E2" events="98" subjects_affected="76" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PRODUCTIVE COUGH</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="373"/>
                <counts group_id="E2" events="27" subjects_affected="23" subjects_at_risk="368"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="373"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="373"/>
                <counts group_id="E2" events="38" subjects_affected="22" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PHOTOSENSITIVITY REACTION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="373"/>
                <counts group_id="E2" events="128" subjects_affected="88" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="373"/>
                <counts group_id="E2" events="25" subjects_affected="21" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="373"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="368"/>
              </event>
              <event>
                <sub_title>SKIN TOXICITY</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="373"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="368"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
      <email>abbvieclinicaltrials@abbvie.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/NCT03033511
org study id: M16-298
secondary id: 2016-003503-64
nct id: NCT03033511
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and
      multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy
      following first-line platinum-based chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
time frame: Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
description: OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
measure: OS in All Randomized Participants
time frame: Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
description: OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
time frame: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
description: The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.
arm group label: Rovalpituzumab tesirine/dexamethasone
arm group type: Experimental
description: Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
arm group label: Placebo
arm group type: Experimental
description: Placebo q6 wk; omitting every third cycle
intervention type: Drug
intervention name: Placebo for dexamethasone
description: Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
arm group label: Placebo
intervention type: Drug
intervention name: Placebo for rovalpituzumab tesirine
description: Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
arm group label: Placebo
intervention type: Drug
intervention name: Rovalpituzumab tesirine
description: Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
arm group label: Rovalpituzumab tesirine/dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
arm group label: Rovalpituzumab tesirine/dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Austria
country: Belarus
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: China
country: Croatia
country: Czechia
country: Denmark
country: Estonia
country: Finland
country: France
country: Germany
country: Greece
country: Hong Kong
country: Hungary
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Mexico
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Sweden
country: Switzerland
country: Taiwan
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
mesh term: Rovalpituzumab tesirine
mesh term: Immunoconjugates
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
provided document: 
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 