<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/NCT03257267</url>
  </required_header>
  <id_info>
    <org_study_id>R2810-ONC-1676</org_study_id>
    <secondary_id>2017-000350-19</secondary_id>
    <nct_id>NCT03257267</nct_id>
  </id_info>
  <brief_title>Study of Cemiplimab in Adults With Cervical Cancer</brief_title>
  <official_title>An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to compare overall survival (OS) for patients with recurrent or&#xD;
      metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have&#xD;
      any eligible histology treated with either cemiplimab or investigator's choice (IC)&#xD;
      chemotherapy.&#xD;
&#xD;
      The secondary objectives performed among SCC patients and among all eligible histologies (SCC&#xD;
      and adenocarcinoma/adenosquamous carcinoma (AC) are:&#xD;
&#xD;
        -  To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy&#xD;
&#xD;
        -  To compare objective response rate (ORR) (partial response [PR] + complete response&#xD;
           [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid&#xD;
           Tumors (RECIST) 1.1&#xD;
&#xD;
        -  To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy&#xD;
&#xD;
        -  To compare the safety profiles of cemiplimab versus IC chemotherapy by describing&#xD;
           adverse events (AE)&#xD;
&#xD;
        -  To compare quality of life (QOL) for patients treated with cemiplimab versus IC&#xD;
           chemotherapy using the European Organization for Research and Treatment of Cancer&#xD;
           Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">April 20, 2023</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Time from randomization to the date of death due to any cause (assessed up to 40 months)</time_frame>
    <description>Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)</time_frame>
    <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1</measure>
    <time_frame>From date of randomization up to 40 months</time_frame>
    <description>ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm) (&lt;1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Assessed Per RECIST 1.1</measure>
    <time_frame>Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)</time_frame>
    <description>DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm (&lt;1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales</measure>
    <time_frame>From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)</time_frame>
    <description>EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 (&quot;not at all&quot;) to 4 (&quot;very much&quot;) except for the items contributing to the GHS/QoL, which are scored 1 (&quot;very poor&quot;) to 7 (&quot;excellent&quot;). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death</measure>
    <time_frame>From date of randomization up to 40 months</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade</measure>
    <time_frame>From date of randomization up to 40 months</time_frame>
    <description>Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">608</enrollment>
  <condition>Squamous Cell Carcinoma (SCC)</condition>
  <condition>Recurrent or Metastatic, Platinum-refractory Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cemiplimab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Investigator choice (IC) chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cemiplimab</intervention_name>
    <description>Intravenous (IV) administration every 3 weeks (Q3W)</description>
    <arm_group_label>Experimental Therapy</arm_group_label>
    <other_name>REGN2810</other_name>
    <other_name>Libtayo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Investigator Choice (IC) Chemotherapy</intervention_name>
    <description>IC chemotherapy options include:&#xD;
Antifolate: Pemetrexed&#xD;
Topoisomerase 1 inhibitor: Topotecan or Irinotecan&#xD;
Nucleoside analogue: Gemcitabine&#xD;
Vinca alkaloid: Vinorelbine&#xD;
The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.</description>
    <arm_group_label>Control Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The criteria listed below are not intended to contain all considerations relevant to a&#xD;
        patient's potential participation in this clinical trial.&#xD;
&#xD;
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology,&#xD;
             for which there is not a curative-intent option (surgery or radiation therapy with or&#xD;
             without chemotherapy).&#xD;
&#xD;
               -  Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous&#xD;
                  carcinoma) as defined in the protocol&#xD;
&#xD;
          2. Tumor progression or recurrence after treatment with platinum therapy (must have been&#xD;
             used to treat metastatic, persistent, or recurrent cervical cancer)&#xD;
&#xD;
          3. Patient must have measurable disease as defined by RECIST 1.1.&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1&#xD;
&#xD;
          5. ≥18 years old&#xD;
&#xD;
          6. Adequate organ or bone marrow function&#xD;
&#xD;
          7. Received prior bevacizumab therapy or had clinically documented reason why not&#xD;
             administered&#xD;
&#xD;
          8. Received prior paclitaxel therapy or had clinically documented reason why not&#xD;
             administered&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that&#xD;
             required treatment with systemic immunosuppressive treatments&#xD;
&#xD;
          2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway&#xD;
&#xD;
          3. Prior treatment with other systemic immune-modulating agents that was&#xD;
&#xD;
               1. within fewer than 4 weeks (28 days) of the enrollment date, or&#xD;
&#xD;
               2. associated with irAEs of any grade within 90 days prior to enrollment, or&#xD;
&#xD;
               3. associated with toxicity that resulted in discontinuation of the immune&#xD;
                  modulating agent&#xD;
&#xD;
          4. Active or untreated brain metastases&#xD;
&#xD;
          5. Immunosuppressive corticosteroid doses (&gt;10 mg prednisone daily or equivalent) within&#xD;
             4 weeks prior to the first dose of study drug cemiplimab or IC chemo)&#xD;
&#xD;
          6. Active infection requiring therapy&#xD;
&#xD;
          7. History of pneumonitis within the last 5 years&#xD;
&#xD;
          8. History of documented allergic reactions or acute hypersensitivity reaction attributed&#xD;
             to antibody treatments&#xD;
&#xD;
          9. Concurrent malignancy other than cervical cancer and/or history of malignancy other&#xD;
             than cervical cancer within 3 years of date of first planned dose of study drug&#xD;
             cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or&#xD;
             death, such as adequately treated cutaneous squamous cell carcinoma or basal cell&#xD;
             carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with&#xD;
             hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion apply&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Oncology Associates</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Research for the Ozarks</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura and Issac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Health of the Carolinas Outpatient Cancer Center</name>
      <address>
        <city>Pinehurst</city>
        <state>North Carolina</state>
        <zip>28374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George Hospital</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern NSW Health District, The Tweed Hospital</name>
      <address>
        <city>Tweed Heads</city>
        <state>New South Wales</state>
        <zip>2485</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brisbane &amp; Women's Hospital</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Centre</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>03000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John of God Subiaco Hospital</name>
      <address>
        <city>Subiaco</city>
        <state>Western Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OLV ziekenhuis Aalst, Medische oncologie- Radiotherapie</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZLeuven Gynaelologic Oncology</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC Saint Joseph</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur site Sainte Elisabeth</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Norte Riograndense Contra o Câncer</name>
      <address>
        <city>Natal</city>
        <state>Rio Grande Do Norte</state>
        <zip>59075-740</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosptial Sao Lucas da PUC de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>09619-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-072</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Novos Tratamentos Itajai</name>
      <address>
        <city>Itajai</city>
        <state>Santa Catarina</state>
        <zip>88301-220</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Pio XII - Hospital de Câncer de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>São Paulo</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisas Clinicas para Estudos Multicentricos - IPCEM</name>
      <address>
        <city>Caxias do Sul</city>
        <zip>95070-560</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancer - INCA</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20220-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto COI de Pesquisa</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Center</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Alexandra</name>
      <address>
        <city>Athens</city>
        <zip>11528</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Ioannina</name>
      <address>
        <city>Ioannina</city>
        <zip>45110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26335</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedica General Clinic, B'Oncology Clinic</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54645</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria di Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O Oncologia Medica P.O Vito Fazzi</name>
      <address>
        <city>Lecce</city>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asst Lecco</name>
      <address>
        <city>Lecco</city>
        <zip>23900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irst Irccs</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AUSL, IRCCS di Reggio Emilia</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Agostino Gemelli IRCCS di Roma</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regina Elena National Cancer Institute</name>
      <address>
        <city>Rome</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>791-0281</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon</city>
        <state>Ehime</state>
        <zip>791-0296</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukui University Hospital</name>
      <address>
        <city>Yoshida-gun</city>
        <state>Fukui</state>
        <zip>910-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8649</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marianna University School of Medicine Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <zip>216-8512</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Ryukyus Hospital</name>
      <address>
        <city>Nakagami-gun</city>
        <state>Okinawa</state>
        <zip>903-0216</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University</name>
      <address>
        <city>Saitama</city>
        <state>Saitama Prefecture</state>
        <zip>350-0495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-Ku</city>
        <state>Tokyo</state>
        <zip>135-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hospital</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <zip>181-8612</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <state>Tokyo</state>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima City Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8761</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41931</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bialostockie Centrum Onkologii</name>
      <address>
        <city>Białystok</city>
        <zip>15-027</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpitale Pomorskie</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center and Institute of Oncology Gliwice</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii Ziemi Lubelskiej im sw. Jana z Dukli</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Poland Cancer Center</name>
      <address>
        <city>Poznań</city>
        <zip>61-866</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Budgetary Institution of Healthcare Ivanovo Regional Oncology Dispensary</name>
      <address>
        <city>Ivanovo</city>
        <state>Ivanovo Region</state>
        <zip>153040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Oncology Dispensary&quot; of Ministry of Healthcare of the Kabardino-Balkarian Republic</name>
      <address>
        <city>Nal'chik</city>
        <state>Kabardino-Balkarian</state>
        <zip>360000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. Tsyb Medical Radiological Research Center</name>
      <address>
        <city>Obninsk</city>
        <state>Kaluga</state>
        <zip>249036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare, Clinical Oncology Dispensary #1 of Ministry of Health of Krasnodar Region</name>
      <address>
        <city>Krasnodar</city>
        <state>Krasnodar Territory</state>
        <zip>350040</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution Leningrad Regional Oncological Dispensary (SBHI &quot;LROD&quot;)</name>
      <address>
        <city>Vsevolozhsk</city>
        <state>Leningrad Region</state>
        <zip>188663</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Autonomous Healthcare Institution ,Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Tatarstan Republic</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budgetary Institution of Healthcare of Omsk region Clinical Oncology Dispensary</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare &quot;Orenburg Regional Clinical Oncology Dispensary&quot;</name>
      <address>
        <city>Orenburg</city>
        <zip>460021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint- Petersburg State Budgetary institution of Healthcare &quot;City Clinical Oncological Dispensary&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <state>Illes Balears</state>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vall d´Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Reina Sofia</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Catalan de Oncologia de Gerona</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario HM Sanchinarro CIOCC</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Instituto Valenciano de Oncologia</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo-Foundation Sun Yat-Sen Cancer Center</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velindre Cancer Centre</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 2TL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde Beatson, West of Scotland Cancer care</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust, Chelsea</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden NHS Foundation Trust, Sutton</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>March 11, 2022</results_first_submitted>
  <results_first_submitted_qc>March 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 6, 2022</results_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cemiplimab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy</ipd_time_frame>
    <ipd_access_criteria>Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf</ipd_access_criteria>
    <ipd_url>https://vivli.org/</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>April 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03257267/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>February 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03257267/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Eligible participants were randomized in a 1:1 ratio to receive cemiplimab or investigator choice of chemotherapy (control treatment determined before randomization by investigator from options per protocol). Randomization was stratified according to histologic type (squamous-cell carcinoma or adenocarcinoma [including adenosquamous carcinoma]), region (N. America/Asia/rest of world), previous bevacizumab exposure (y/n), &amp; Eastern Cooperative Oncology Group (ECOG) performance-status score (0/1).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cemiplimab</title>
          <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
        </group>
        <group group_id="P2">
          <title>Investigator Choice (IC) Chemotherapy</title>
          <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="304"/>
                <participants group_id="P2" count="304"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="304"/>
                <participants group_id="P2" count="304"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAF)</title>
              <participants_list>
                <participants group_id="P1" count="300"/>
                <participants group_id="P2" count="290"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Treatment</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="297"/>
                <participants group_id="P2" count="304"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Decision</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="117"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The FAS included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Cemiplimab</title>
          <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
        </group>
        <group group_id="B2">
          <title>Investigator Choice (IC) Chemotherapy</title>
          <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</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="304"/>
            <count group_id="B2" value="304"/>
            <count group_id="B3" value="608"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.0" lower_limit="22" upper_limit="81"/>
                    <measurement group_id="B2" value="50.0" lower_limit="24" upper_limit="87"/>
                    <measurement group_id="B3" value="51.0" lower_limit="22" upper_limit="87"/>
                  </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="304"/>
                    <measurement group_id="B2" value="304"/>
                    <measurement group_id="B3" value="608"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="250"/>
                    <measurement group_id="B3" value="501"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="193"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="88"/>
                    <measurement group_id="B3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.</description>
        <time_frame>Time from randomization to the date of death due to any cause (assessed up to 40 months)</time_frame>
        <population>The full analysis set (FAS) included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.</description>
          <population>The full analysis set (FAS) included all randomized participants.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="304"/>
                <count group_id="O2" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="10.3" upper_limit="13.5"/>
                    <measurement group_id="O2" value="8.5" lower_limit="7.5" upper_limit="9.6"/>
                  </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>0.00011</p_value>
            <p_value_desc>One-sided p-value</p_value_desc>
            <method>Stratified Log-rank Test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.685</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.560</ci_lower_limit>
            <ci_upper_limit>0.838</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</title>
        <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.</description>
        <time_frame>Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)</time_frame>
        <population>The FAS included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</title>
          <description>PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.</description>
          <population>The FAS included all randomized participants.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="304"/>
                <count group_id="O2" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.6" upper_limit="3.9"/>
                    <measurement group_id="O2" value="2.9" lower_limit="2.7" upper_limit="3.4"/>
                  </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>0.00048</p_value>
            <method>Stratified Log-rank Test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.745</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.625</ci_lower_limit>
            <ci_upper_limit>0.890</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1</title>
        <description>ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm) (&lt;1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From date of randomization up to 40 months</time_frame>
        <population>The FAS included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1</title>
          <description>ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeters (mm) (&lt;1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>The FAS included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="304"/>
                <count group_id="O2" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="19"/>
                  </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>0.00004</p_value>
            <method>Stratified Cochran-Mantel-Haenszel test</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.984</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.707</ci_lower_limit>
            <ci_upper_limit>5.215</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Assessed Per RECIST 1.1</title>
        <description>DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm (&lt;1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.</description>
        <time_frame>Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)</time_frame>
        <population>The FAS included all randomized participants with confirmed CR or PR</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Assessed Per RECIST 1.1</title>
          <description>DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm (&lt;1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.</description>
          <population>The FAS included all randomized participants with confirmed CR or PR</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" lower_limit="12.4" upper_limit="NA">Data could not be estimated due to higher number (&gt; 50%) of censored participants.</measurement>
                    <measurement group_id="O2" value="6.9" lower_limit="5.1" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales</title>
        <description>EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 (&quot;not at all&quot;) to 4 (&quot;very much&quot;) except for the items contributing to the GHS/QoL, which are scored 1 (&quot;very poor&quot;) to 7 (&quot;excellent&quot;). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.</description>
        <time_frame>From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)</time_frame>
        <population>The FAS included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales</title>
          <description>EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 (&quot;not at all&quot;) to 4 (&quot;very much&quot;) except for the items contributing to the GHS/QoL, which are scored 1 (&quot;very poor&quot;) to 7 (&quot;excellent&quot;). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.</description>
          <population>The FAS included all randomized participants.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="304"/>
                <count group_id="O2" value="304"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" lower_limit="-2.033" upper_limit="4.047"/>
                    <measurement group_id="O2" value="-6.81" lower_limit="-10.977" upper_limit="-2.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" lower_limit="-3.197" upper_limit="2.298"/>
                    <measurement group_id="O2" value="-8.70" lower_limit="-12.300" upper_limit="-5.110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.</description>
        <time_frame>From date of randomization up to 40 months</time_frame>
        <population>The safety analysis set (SAF) included all randomized participants who received any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.</description>
          <population>The safety analysis set (SAF) included all randomized participants who received any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="265"/>
                    <measurement group_id="O2" value="265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with any Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with any TEAE leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade</title>
        <description>Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.</description>
        <time_frame>From date of randomization up to 40 months</time_frame>
        <population>The SAF included all randomized participants who received any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cemiplimab</title>
            <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
          <group group_id="O2">
            <title>Investigator Choice (IC) Chemotherapy</title>
            <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade</title>
          <description>Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.</description>
          <population>The SAF included all randomized participants who received any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology (Grades 3/4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="278"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Electrolytes (Grades 3/4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chemistry (Other) (Grades 3/4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver Function (Grades 3/4)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 40 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cemiplimab</title>
          <description>Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
        </group>
        <group group_id="E2">
          <title>Investigator Choice (IC) Chemotherapy</title>
          <description>Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</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="181" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="206" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="81" subjects_at_risk="290"/>
              </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="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="18" subjects_affected="14" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Autoimmune pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Diverticular perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Colonic fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Oral papule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Rectal perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Catheter site thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hyperpyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Soft tissue inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vascular stent thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Infected lymphocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pelvic abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Toxic shock syndrome streptococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pyomyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Stoma site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cystitis radiation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Device use error</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase MB increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Personality change</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </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="5" subjects_affected="5" subjects_at_risk="300"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Female genital tract fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="300"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Subclavian vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</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="263" subjects_at_risk="300"/>
                <counts group_id="E2" subjects_affected="264" subjects_at_risk="290"/>
              </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="94" subjects_affected="75" subjects_at_risk="300"/>
                <counts group_id="E2" events="159" subjects_affected="127" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="300"/>
                <counts group_id="E2" events="74" subjects_affected="44" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="67" subjects_affected="59" subjects_at_risk="300"/>
                <counts group_id="E2" events="172" subjects_affected="97" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="61" subjects_affected="47" subjects_at_risk="300"/>
                <counts group_id="E2" events="101" subjects_affected="66" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="50" subjects_affected="46" subjects_at_risk="300"/>
                <counts group_id="E2" events="64" subjects_affected="59" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="55" subjects_affected="32" subjects_at_risk="300"/>
                <counts group_id="E2" events="60" subjects_affected="41" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="300"/>
                <counts group_id="E2" events="51" subjects_affected="34" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="300"/>
                <counts group_id="E2" events="24" subjects_affected="22" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="48" subjects_affected="32" subjects_at_risk="300"/>
                <counts group_id="E2" events="115" subjects_affected="61" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="33" subjects_at_risk="300"/>
                <counts group_id="E2" events="63" subjects_affected="45" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="53" subjects_affected="51" subjects_at_risk="300"/>
                <counts group_id="E2" events="81" subjects_affected="45" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="300"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="300"/>
                <counts group_id="E2" events="64" subjects_affected="26" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="26" subjects_affected="20" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="18" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="23" subjects_affected="17" subjects_at_risk="300"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="300"/>
                <counts group_id="E2" events="34" subjects_affected="16" subjects_at_risk="290"/>
              </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="48" subjects_affected="45" subjects_at_risk="300"/>
                <counts group_id="E2" events="55" subjects_affected="46" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="300"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="300"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="300"/>
                <counts group_id="E2" events="21" subjects_affected="16" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="37" subjects_affected="34" subjects_at_risk="300"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="34" subjects_affected="31" subjects_at_risk="300"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="300"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="39" subjects_affected="22" subjects_at_risk="300"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="19" subjects_at_risk="300"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="300"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="300"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="290"/>
              </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="24" subjects_affected="20" subjects_at_risk="300"/>
                <counts group_id="E2" events="28" subjects_affected="21" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="300"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="28" subjects_affected="18" subjects_at_risk="300"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="300"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Administrator</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc</organization>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.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/NCT03257267
org study id: R2810-ONC-1676
secondary id: 2017-000350-19
nct id: NCT03257267
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective is to compare overall survival (OS) for patients with recurrent or
      metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have
      any eligible histology treated with either cemiplimab or investigator's choice (IC)
      chemotherapy.

      The secondary objectives performed among SCC patients and among all eligible histologies (SCC
      and adenocarcinoma/adenosquamous carcinoma (AC) are:

        -  To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy

        -  To compare objective response rate (ORR) (partial response [PR] + complete response
           [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid
           Tumors (RECIST) 1.1

        -  To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy

        -  To compare the safety profiles of cemiplimab versus IC chemotherapy by describing
           adverse events (AE)

        -  To compare quality of life (QOL) for patients treated with cemiplimab versus IC
           chemotherapy using the European Organization for Research and Treatment of Cancer
           Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival (OS)
time frame: Time from randomization to the date of death due to any cause (assessed up to 40 months)
description: Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
measure: Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
description: PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.
measure: Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
time frame: From date of randomization up to 40 months
description: ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm) (<1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
measure: Duration of Response (DOR) Assessed Per RECIST 1.1
time frame: Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)
description: DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.
measure: Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales
time frame: From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
description: EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
time frame: From date of randomization up to 40 months
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.
measure: Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
time frame: From date of randomization up to 40 months
description: Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.
arm group label: Experimental Therapy
arm group type: Experimental
description: Cemiplimab
arm group label: Control Therapy
arm group type: Active Comparator
description: Investigator choice (IC) chemotherapy
intervention type: Drug
intervention name: Cemiplimab
description: Intravenous (IV) administration every 3 weeks (Q3W)
arm group label: Experimental Therapy
other name: REGN2810
other name: Libtayo
intervention type: Drug
intervention name: Investigator Choice (IC) Chemotherapy
description: IC chemotherapy options include:
Antifolate: Pemetrexed
Topoisomerase 1 inhibitor: Topotecan or Irinotecan
Nucleoside analogue: Gemcitabine
Vinca alkaloid: Vinorelbine
The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above.
arm group label: Control Therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: Australia
country: Belgium
country: Brazil
country: Canada
country: Greece
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Uterine Cervical Neoplasms
mesh term: Cemiplimab
sharing ipd: Yes
ipd description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy
ipd access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
ipd url: https://vivli.org/
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 