<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/NCT03829332</url>
  </required_header>
  <id_info>
    <org_study_id>7902-007</org_study_id>
    <secondary_id>MK-7902-007</secondary_id>
    <secondary_id>E7080-G000-314</secondary_id>
    <secondary_id>LEAP-007</secondary_id>
    <secondary_id>194670</secondary_id>
    <secondary_id>2018-003794-98</secondary_id>
    <nct_id>NCT03829332</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (MK-7902/E7080) in Adults With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Treatment-naïve Nonsmall Cell Lung Cancer (NSCLC) (MK-7902-007/E7080-G000-314/LEAP-007)</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</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 purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)&#xD;
      combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for&#xD;
      lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic&#xD;
      non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1)&#xD;
      Tumor Proportion Score (TPS) greater than or equal to 1%.&#xD;
&#xD;
      The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is&#xD;
      superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response&#xD;
      Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of&#xD;
      pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall&#xD;
      Survival (OS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s)&#xD;
      involved in the treatment administration or clinical evaluation of the participants will be&#xD;
      unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain&#xD;
      on treatment will receive open-label pembrolizumab only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Anticipated">March 8, 2024</completion_date>
  <primary_completion_date type="Actual">May 19, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 25 months</time_frame>
    <description>PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 25 months</time_frame>
    <description>OS was defined as the time from date of randomization to date of death from any cause. OS is presented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</measure>
    <time_frame>Up to approximately 25 months</time_frame>
    <description>ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experience an Adverse Event (AE)</measure>
    <time_frame>Through 90 days post last dose of study treatment (Up to approximately 27 months)</time_frame>
    <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</measure>
    <time_frame>Through last dose of study treatment (Up to approximately 24 months)</time_frame>
    <description>The number of participants who discontinue study treatment due to an AE will be presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot;How would you rate your overall health during the past week?&quot; are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot; How would you rate your overall quality of life during the past week?&quot; are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question &quot;How much did you cough?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question &quot;Have you had pain in your chest?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot;Were you short of breath?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score</measure>
    <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
    <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">623</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab + Lenvatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pembrolizumab + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>IV infusion</description>
    <arm_group_label>Pembrolizumab + Lenvatinib</arm_group_label>
    <arm_group_label>Pembrolizumab + Placebo</arm_group_label>
    <other_name>MK-3475</other_name>
    <other_name>KEYTRUDA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenvatinib</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Pembrolizumab + Lenvatinib</arm_group_label>
    <other_name>MK-7902</other_name>
    <other_name>E7080</other_name>
    <other_name>LENVIMA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for lenvatinib</intervention_name>
    <description>oral capsule</description>
    <arm_group_label>Pembrolizumab + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a histologically or cytologically confirmed diagnosis of NSCLC.&#xD;
&#xD;
          -  Has Stage IV NSCLC (American Joint Committee on Cancer [AJCC 8th edition]).&#xD;
&#xD;
          -  Has measurable disease based on RECIST 1.1.&#xD;
&#xD;
          -  Has tumor tissue that demonstrates programmed cell death-ligand 1 (PD-L1) expression&#xD;
             in ≥1% of tumor cells (Tumor Proportion Score [TPS] ≥1%) as assessed by&#xD;
             immunohistochemistry (IHC) 22C3 pharmDx assay (Dako North America, Inc.) at a central&#xD;
             laboratory.&#xD;
&#xD;
          -  Has a life expectancy of ≥3 months.&#xD;
&#xD;
          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7&#xD;
             days before the first dose of study treatment but before randomization.&#xD;
&#xD;
          -  Male participants must agree to the following during the treatment period and for ≥7&#xD;
             days after the last dose of lenvatinib/matching placebo: 1) Be abstinent from&#xD;
             heterosexual intercourse as their preferred and usual lifestyle and agree to remain&#xD;
             abstinent, OR 2) Must agree to use contraception unless confirmed to be azoospermic&#xD;
             (vasectomized or secondary to medical cause).&#xD;
&#xD;
          -  Female participants are eligible to participate if not pregnant or breastfeeding, and&#xD;
             ≥1 of the following applies: 1) Is not a woman of child-bearing potential (WOCBP), OR&#xD;
             2) Is a WOCBP and is using a highly effective contraceptive method that has a low user&#xD;
             dependency, or be abstinent from heterosexual intercourse as their preferred and usual&#xD;
             lifestyle during the treatment period and for ≥120 days post pembrolizumab or ≥30 days&#xD;
             post lenvatinib/matching placebo, whichever occurs last.&#xD;
&#xD;
          -  Has adequately controlled blood pressure (BP) with or without antihypertensive&#xD;
             medications, defined as BP ≤150/90 mm Hg and no change in antihypertensive medications&#xD;
             within 1 week before randomization.&#xD;
&#xD;
          -  Has adequate organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has known untreated central nervous system metastases and/or carcinomatous meningitis.&#xD;
&#xD;
          -  Has active hemoptysis (at least 0.5 teaspoon of bright red blood) within 2 weeks prior&#xD;
             to the first dose of study intervention.&#xD;
&#xD;
          -  Has radiographic evidence of intratumoral cavitations, encasement, or invasion of a&#xD;
             major blood vessel.&#xD;
&#xD;
          -  Has a known history of an additional malignancy, except if the participant has&#xD;
             undergone potentially curative therapy with no evidence of that disease recurrence for&#xD;
             ≥3 years since initiation of that therapy. (Note: The time requirement does not apply&#xD;
             to participants who underwent successful definitive resection of basal cell carcinoma&#xD;
             of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ&#xD;
             cervical cancer, or other in situ cancers.)&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in the past 2&#xD;
             years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment and is allowed.&#xD;
&#xD;
          -  Has had an allogeneic tissue/solid organ transplant.&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Has a history of (noninfectious) pneumonitis that required systemic steroids or&#xD;
             current pneumonitis/interstitial lung disease.&#xD;
&#xD;
          -  Has a known history of hepatitis B or known active hepatitis C virus infection.&#xD;
&#xD;
          -  Has a history of a gastrointestinal condition or procedure that in the opinion of the&#xD;
             investigator may affect oral study drug absorption.&#xD;
&#xD;
          -  Has significant cardiovascular impairment within 12 months of the first dose of study&#xD;
             treatment, such as a history of congestive heart failure greater than New York Heart&#xD;
             Association Class II, unstable angina, myocardial infarction, cerebrovascular&#xD;
             accident/stroke, or cardiac arrhythmia associated with hemodynamic instability.&#xD;
&#xD;
          -  Has not recovered adequately from any toxicity and/or complications from major surgery&#xD;
             before starting study treatment.&#xD;
&#xD;
          -  Has a known history of active tuberculosis (TB).&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy.&#xD;
&#xD;
          -  Has previously had a severe hypersensitivity reaction to treatment with a monoclonal&#xD;
             antibody or has a known sensitivity or intolerance to any component of lenvatinib or&#xD;
             pembrolizumab.&#xD;
&#xD;
          -  Has received prior systemic chemotherapy or other targeted or biological&#xD;
             antineoplastic therapy for their metastatic NSCLC.&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with&#xD;
             an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.&#xD;
             cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor&#xD;
             superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9&#xD;
             [CD137]) or has received lenvatinib as monotherapy or in combination with anti-&#xD;
             programmed cell death protein (anti-PD-1) agents.&#xD;
&#xD;
          -  Has received radiotherapy within 14 days before the first dose of study treatment or&#xD;
             received lung radiation therapy of &gt;30 Gray (Gy) within 6 months before the first dose&#xD;
             of study treatment. (Note: Participants must have recovered from all radiation-related&#xD;
             toxicities to ≤Grade 1, not require corticosteroids, and not have had radiation&#xD;
             pneumonitis.)&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive&#xD;
             therapy within 7 days before the first dose of study treatment.&#xD;
&#xD;
          -  Is receiving systemic steroid therapy (doses &gt;10 mg daily of prednisone equivalent)&#xD;
             within 7 days before the first dose of study treatment.&#xD;
&#xD;
          -  Has received a live or attenuated vaccine within 30 days before the first dose of&#xD;
             study treatment.&#xD;
&#xD;
          -  Has had major surgery within 3 weeks prior to first dose of study treatment&#xD;
&#xD;
          -  Has pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alaska Clinical Research Center ( Site 0511)</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ironwood Cancer &amp; Research Centers ( Site 0541)</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBCC Global Research, Inc. ( Site 0532)</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Cancer Center ( Site 0521)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital ( Site 0526)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Centers PC ( Site 0518)</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Care, PC ( Site 0557)</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Cancer Center ( Site 0542)</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky School of Medicine &amp; Hospitals ( Site 0517)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anne Arundel Medical Center Oncology and Hematology ( Site 0514)</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center ( Site 0512)</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Frauenshuh Cancer Center ( Site 0554)</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri Health Care ( Site 0555)</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center ( Site 0508)</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health Cancer Center at Alamance Regional ( Site 0527)</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Cancer Care Center ( Site 0559)</name>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health Sciences University ( Site 0544)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Veterans Healthcare System ( Site 0533)</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange Health Services ( Site 0002)</name>
      <address>
        <city>Orange</city>
        <state>New South Wales</state>
        <zip>2800</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wollongong Private Hospital ( Site 0005)</name>
      <address>
        <city>Wollongong</city>
        <state>New South Wales</state>
        <zip>2500</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital ( Site 0011)</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ballarat Oncology and Haematology Services ( Site 0008)</name>
      <address>
        <city>Wendouree</city>
        <state>Victoria</state>
        <zip>3355</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St John of God Murdoch Medical Clinic ( Site 0001)</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute ( Site 0400)</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lions Gate Hospital ( Site 0407)</name>
      <address>
        <city>North Vancouver</city>
        <state>British Columbia</state>
        <zip>V7L 2L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Osler Health System (Brampton Civic Hospital) ( Site 0402)</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Windsor Regional Cancer Program ( Site 0404)</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 2X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre ( Site 0418)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chest Hospital Capital Medical University ( Site 0111)</name>
      <address>
        <city>Beijing</city>
        <state>Anhui</state>
        <zip>101149</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital ( Site 0108)</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University ( Site 0113)</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital ( Site 0105)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital ( Site 0102)</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital of Central South University ( Site 0115)</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital ( Site 0104)</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital ( Site 0101)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University ( Site 0110)</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University ( Site 0100)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital ( Site 0112)</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)</name>
      <address>
        <city>XiAn</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University ( Site 0117)</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>510115</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Zhejiang University ( Site 0106)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital ( Site 0109)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital ( Site 0116)</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050015</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Centro de Investigacion Clinica CIC ( Site 0366)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050021</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biomelab S A S ( Site 0365)</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlantico</state>
        <zip>080002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)</name>
      <address>
        <city>Valledupar</city>
        <state>Cesar</state>
        <zip>200001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncomedica S.A. ( Site 0372)</name>
      <address>
        <city>Monteria</city>
        <state>Cordoba</state>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Imbanaco de Cali S.A ( Site 0369)</name>
      <address>
        <city>Cali</city>
        <state>Valle Del Cauca</state>
        <zip>760023</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AS Ida-Tallinna Keskhaigla ( Site 0161)</name>
      <address>
        <city>Tallinn</city>
        <state>Harjumaa</state>
        <zip>11312</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SA Pohja-Eesti Regionaalhaigla ( Site 0162)</name>
      <address>
        <city>Tallin</city>
        <state>Harjumaa</state>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SA Tartu Ulikooli Kliinikum ( Site 0160)</name>
      <address>
        <city>Tartu</city>
        <state>Tartumaa</state>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Jean Minjoz ( Site 0167)</name>
      <address>
        <city>Besancon</city>
        <state>Doubs</state>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie - Centre Rene Huguenin ( Site 0181)</name>
      <address>
        <city>Saint-Cloud</city>
        <state>Hauts-de-Seine</state>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICM Val D Auerelle ( Site 0177)</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble - Hopital Michallon ( Site 0169)</name>
      <address>
        <city>La Tronche</city>
        <state>Isere</state>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)</name>
      <address>
        <city>Saint Herblain</city>
        <state>Loire-Atlantique</state>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Cote Basque ( Site 0173)</name>
      <address>
        <city>Bayonne</city>
        <state>Pyrenees-Atlantiques</state>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen ( Site 0174)</name>
      <address>
        <city>Rouen</city>
        <state>Seine-Maritime</state>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens Sud ( Site 0182)</name>
      <address>
        <city>Amiens</city>
        <state>Somme</state>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Toulon Sainte-Musse ( Site 0172)</name>
      <address>
        <city>Toulon</city>
        <state>Var</state>
        <zip>83056</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie ( Site 0166)</name>
      <address>
        <city>Paris</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)</name>
      <address>
        <city>Gyula</city>
        <state>Bekes</state>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRU Hungary KFT ( Site 0209)</name>
      <address>
        <city>Miskolc</city>
        <state>Borsod-Abauj-Zemplen</state>
        <zip>3529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladar Megyei Oktato Korhaz ( Site 0213)</name>
      <address>
        <city>Gyor</city>
        <state>Gyor-Moson-Sopron</state>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)</name>
      <address>
        <city>Szolnok</city>
        <state>Jasz-Nagykun-Szolnok</state>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tudogyogyintezet Torokbalint ( Site 0205)</name>
      <address>
        <city>Torokbalint</city>
        <state>Pest</state>
        <zip>2045</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem ( Site 0210)</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)</name>
      <address>
        <city>Kaposvar</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnei Zion Medical Center ( Site 0227)</name>
      <address>
        <city>Haifa</city>
        <state>Heifa</state>
        <zip>3339419</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center ( Site 0220)</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel Aviv</state>
        <zip>5266202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center ( Site 0222)</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8457108</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center ( Site 0223)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center ( Site 0221)</name>
      <address>
        <city>Kfar-Saba</city>
        <zip>4428132</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center ( Site 0224)</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center ( Site 0225)</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center ( Site 0226)</name>
      <address>
        <city>Ashkelon</city>
        <state>Ḥeifā</state>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero San Vincenzo ( Site 0231)</name>
      <address>
        <city>Taormina</city>
        <state>Messina</state>
        <zip>98039</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico CRO ( Site 0235)</name>
      <address>
        <city>Aviano</city>
        <state>Pordenone</state>
        <zip>33081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)</name>
      <address>
        <city>Avellino</city>
        <zip>83100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Magna Grecia ( Site 0230)</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Universitaria Careggi ( Site 0236)</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria delle Croci ( Site 0232)</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Gemelli di Roma ( Site 0237)</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital ( Site 0018)</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital ( Site 0025)</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center ( Site 0021)</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <zip>673-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center ( Site 0026)</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center ( Site 0023)</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miyagi Cancer Center ( Site 0028)</name>
      <address>
        <city>Natori</city>
        <state>Miyagi</state>
        <zip>981-1293</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital ( Site 0022)</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital ( Site 0017)</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center ( Site 0015)</name>
      <address>
        <city>Fukuoka</city>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital ( Site 0030)</name>
      <address>
        <city>Fukuoka</city>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital ( Site 0020)</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute ( Site 0019)</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital ( Site 0016)</name>
      <address>
        <city>Tokyo</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital ( Site 0029)</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital ( Site 0024)</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital ( Site 0079)</name>
      <address>
        <city>Cheongju si</city>
        <state>Chungbuk</state>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital ( Site 0075)</name>
      <address>
        <city>Seongnam-si</city>
        <state>Kyonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital ( Site 0077)</name>
      <address>
        <city>Ulsan</city>
        <state>Ulsan-Kwangyokshi</state>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 0076)</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMG-SNU Boramae Medical Center ( Site 0078)</name>
      <address>
        <city>Seoul</city>
        <zip>07061</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Tengku Ampuan Afzan ( Site 0062)</name>
      <address>
        <city>Kuantan</city>
        <state>Pahang</state>
        <zip>25100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pulau Pinang. ( Site 0065)</name>
      <address>
        <city>Georgetown</city>
        <state>Pulau Pinang</state>
        <zip>10990</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarawak General Hospital ( Site 0064)</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>93586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Hospital Sdn Bhd ( Site 0067)</name>
      <address>
        <city>Petaling Jaya</city>
        <state>Selangor</state>
        <zip>46050</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Kanser Negara - National Cancer Institute ( Site 0063)</name>
      <address>
        <city>Putrajaya</city>
        <state>Wilayah Persekutuan Putrajaya</state>
        <zip>62250</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Centre ( Site 0061)</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gleneagles Penang ( Site 0066)</name>
      <address>
        <city>Pulau Pinang</city>
        <zip>10050</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Sur S.A.B de C.V. ( Site 0384)</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorios de Medicina Especializada del Sector Privado ( Site 0388)</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44680</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)</name>
      <address>
        <city>Madero</city>
        <state>Tamaulipas</state>
        <zip>89440</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerologia. ( Site 0382)</name>
      <address>
        <city>Mexico City</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oaxaca Site Management Organization SC ( Site 0389)</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>99-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)</name>
      <address>
        <city>Zielona Gora</city>
        <state>Lubuskie</state>
        <zip>65-046</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Ostroleka ( Site 0242)</name>
      <address>
        <city>Ostroleka</city>
        <state>Mazowieckie</state>
        <zip>07-410</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)</name>
      <address>
        <city>Przemysl</city>
        <state>Podkarpackie</state>
        <zip>37-700</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ars Medical Sp. z o.o. ( Site 0254)</name>
      <address>
        <city>Pila</city>
        <state>Wielkopolskie</state>
        <zip>64-920</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)</name>
      <address>
        <city>Ufa</city>
        <state>Baskortostan, Respublika</state>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)</name>
      <address>
        <city>Krasnoyarsk</city>
        <state>Krasnoyarskiy Kray</state>
        <zip>660133</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)</name>
      <address>
        <city>Samara</city>
        <state>Samarskaya Oblast</state>
        <zip>443031</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI Leningrad Regional Clinical Hospital ( Site 0263)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Railway Hospital of OJSC ( Site 0268)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Center ( Site 0260)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Sankt-Peterburg</state>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan, Respublika</state>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)</name>
      <address>
        <city>Hsinchu</city>
        <zip>300</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Shuang Ho Hospital ( Site 0090)</name>
      <address>
        <city>New Taipei</city>
        <zip>235</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital ( Site 0086)</name>
      <address>
        <city>Tainan</city>
        <zip>70457</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital ( Site 0088)</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital ( Site 0089)</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)</name>
      <address>
        <city>Konya</city>
        <state>Adana</state>
        <zip>42080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)</name>
      <address>
        <city>Ankara</city>
        <zip>06200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baskent Universitesi Ankara Hastanesi ( Site 0319)</name>
      <address>
        <city>Ankara</city>
        <zip>06490</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)</name>
      <address>
        <city>Antalya</city>
        <zip>07020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akdeniz Universitesi Tip Fakultesi ( Site 0322)</name>
      <address>
        <city>Antalya</city>
        <zip>07070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)</name>
      <address>
        <city>Sakarya</city>
        <zip>54290</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsun Medical Park Hastanesi ( Site 0320)</name>
      <address>
        <city>Samsun</city>
        <zip>55200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cherkasy Regional Hospital ( Site 0336)</name>
      <address>
        <city>Cherkasy</city>
        <state>Cherkaska Oblast</state>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hosp.4 of DCC ( Site 0338)</name>
      <address>
        <city>Dnipro</city>
        <state>Dnipropetrovska Oblast</state>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Precarpathian Clinical Oncology Center ( Site 0346)</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <state>Ivano-Frankivska Oblast</state>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Centre of Oncology-Thoracic organs ( Site 0337)</name>
      <address>
        <city>Kharkiv</city>
        <state>Kharkivska Oblast</state>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ukranian Center of TomoTherapy ( Site 0344)</name>
      <address>
        <city>Kropyvnytskiy</city>
        <state>Kirovohradska Oblast</state>
        <zip>25011</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Verum ( Site 0334)</name>
      <address>
        <city>Kyiv</city>
        <state>Kyivska Oblast</state>
        <zip>03039</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Oncology Centre ( Site 0339)</name>
      <address>
        <city>Kyiv</city>
        <state>Kyivska Oblast</state>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)</name>
      <address>
        <city>Kyiv</city>
        <state>Kyivska Oblast</state>
        <zip>03126</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)</name>
      <address>
        <city>Lviv</city>
        <state>Lvivska Oblast</state>
        <zip>79031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Odessa Regional Oncological Centre ( Site 0333)</name>
      <address>
        <city>Odesa</city>
        <state>Odeska Oblast</state>
        <zip>65055</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podillya Regional Center of Oncology ( Site 0343)</name>
      <address>
        <city>Vinnytsia</city>
        <state>Vinnytska Oblast</state>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trial Information</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>May 6, 2022</results_first_submitted>
  <results_first_submitted_qc>May 6, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 2, 2022</results_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>programmed cell death 1 (PD-1, PD1)</keyword>
  <keyword>programmed cell death-ligand 1 (PD-L1, PDL1)</keyword>
  <keyword>programmed cell death-ligand 2 (PD-L2, PDL2)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pembrolizumab</mesh_term>
    <mesh_term>Lenvatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03829332/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Of the 623 total participants randomized in the MK-7902-007 global study, 80 were also randomized in the China extension study for MK-7902-007 (NCT04676412).</recruitment_details>
      <pre_assignment_details>Of the 623 randomized participants, 621 received treatment. As of the 19-May-2021 database cut-off, 329 participants were ongoing in the study for long-term safety and survival follow-up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab + Lenvatinib</title>
          <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
        </group>
        <group group_id="P2">
          <title>Pembrolizumab + Placebo</title>
          <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="314"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="312"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="314"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="135"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing in Study</title>
              <participants_list>
                <participants group_id="P1" count="154"/>
                <participants group_id="P2" count="175"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants randomized by intention to treat (ITT).</population>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab + Lenvatinib</title>
          <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
        </group>
        <group group_id="B2">
          <title>Pembrolizumab + Placebo</title>
          <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</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="309"/>
            <count group_id="B2" value="314"/>
            <count group_id="B3" value="623"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.6" spread="9.6"/>
                    <measurement group_id="B2" value="65.4" spread="8.8"/>
                    <measurement group_id="B3" value="65.0" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                    <measurement group_id="B2" value="224"/>
                    <measurement group_id="B3" value="454"/>
                  </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="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="266"/>
                    <measurement group_id="B2" value="269"/>
                    <measurement group_id="B3" value="535"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="193"/>
                    <measurement group_id="B3" value="381"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>Randomization of participants in the study was stratified by an ECOG Performance Status of 0 (Fully active, able to carry on all pre-disease performance without restriction) or 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ECOG = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Programmed Cell Death Ligand 1 (PD-L1) Status at Baseline</title>
          <description>Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Randomization of participants in the study was stratified by PD-L1 tumor proportion score (TPS) at baseline (1-49% or ≥ 50%). Higher percentages of PD-L1 TPS staining correspond to higher positivity of PD-L1 on a tumor.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>TPS = 1-49%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TPS = ≥ 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic Region</title>
          <description>Randomization of participants in this study was stratified by geographic region of the enrolling site (East Asia or non-East Asia).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>East Asia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-East Asia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="206"/>
                    <measurement group_id="B2" value="210"/>
                    <measurement group_id="B3" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
        <description>PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.</description>
        <time_frame>Up to approximately 25 months</time_frame>
        <population>The analysis population consisted of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Lenvatinib</title>
            <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
          <description>PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.</description>
          <population>The analysis population consisted of 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="309"/>
                <count group_id="O2" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" lower_limit="6.1" upper_limit="8.2"/>
                    <measurement group_id="O2" value="4.2" lower_limit="4.1" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (1% to 49% versus &gt;=50%).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.00624</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from date of randomization to date of death from any cause. OS is presented.</description>
        <time_frame>Up to approximately 25 months</time_frame>
        <population>The analysis population consisted of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Lenvatinib</title>
            <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from date of randomization to date of death from any cause. OS is presented.</description>
          <population>The analysis population consisted of 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="309"/>
                <count group_id="O2" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" lower_limit="11.4" upper_limit="19.0"/>
                    <measurement group_id="O2" value="16.4" lower_limit="12.6" upper_limit="20.6"/>
                  </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>
            <groups_desc>Comparison based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (1% to 49% versus &gt;=50%).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.79744</p_value>
            <method>Stratified Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by ECOG performance status, geographic region of the enrolling site, and baseline PD-L1 status.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.39</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
        <description>ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.</description>
        <time_frame>Up to approximately 25 months</time_frame>
        <population>The analysis population consisted of all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Lenvatinib</title>
            <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)</title>
          <description>ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.</description>
          <population>The analysis population consisted of all randomized participants.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="314"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" lower_limit="34.9" upper_limit="46.2"/>
                    <measurement group_id="O2" value="27.7" lower_limit="22.8" upper_limit="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison based on Miettinen &amp; Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and Baseline PD-L1 Status (1% to 49% versus &gt;=50%).</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.00037</p_value>
            <method>Stratified Miettinen &amp; Nurminen</method>
            <method_desc>One-sided p-value for testing. H0: difference in percent = 0 versus H1: difference in percent &gt; 0.</method_desc>
            <param_type>Percent Difference</param_type>
            <param_value>12.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.4</ci_lower_limit>
            <ci_upper_limit>20.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experience an Adverse Event (AE)</title>
        <description>An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.</description>
        <time_frame>Through 90 days post last dose of study treatment (Up to approximately 27 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)</title>
        <description>The number of participants who discontinue study treatment due to an AE will be presented.</description>
        <time_frame>Through last dose of study treatment (Up to approximately 24 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score</title>
        <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot;How would you rate your overall health during the past week?&quot; are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score</title>
        <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot; How would you rate your overall quality of life during the past week?&quot; are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score</title>
        <description>The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question &quot;How much did you cough?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score</title>
        <description>The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question &quot;Have you had pain in your chest?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score</title>
        <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question &quot;Were you short of breath?&quot; are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score</title>
        <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score</title>
        <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score</title>
        <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)</title>
        <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score</title>
        <description>TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.</description>
        <time_frame>Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)</time_frame>
        <posting_date>03/2025</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 25 months</time_frame>
      <desc>All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms &quot;Neoplasm progression&quot;, &quot;Malignant neoplasm progression&quot; &amp; &quot;Disease progression&quot; not related to study treatment are excluded as AEs. Data are reported by treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lenvatinib + Pembrolizumab</title>
          <description>Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Pembrolizumab</title>
          <description>Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="149" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="137" subjects_at_risk="314"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="175" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="106" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Immune-mediated myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pericardial haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Tracheo-oesophageal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Intestinal pseudo-obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Intra-abdominal fluid collection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Oral cavity fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Strangulated hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Immune-mediated hepatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Portal hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="31" subjects_affected="28" subjects_at_risk="309"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumonia fungal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumonia pseudomonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Coagulation time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Electrocardiogram ST segment elevation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </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="7" subjects_affected="7" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Connective tissue disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Soft tissue mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Skin angiosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Tumour necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Demyelination</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Bronchial fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Immune-mediated lung disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="309"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Oesophagobronchial fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pharyngeal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="309"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Immune-mediated dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Red man syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Skin lesion inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="292" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="269" subjects_at_risk="312"/>
              </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="67" subjects_affected="50" subjects_at_risk="309"/>
                <counts group_id="E2" events="79" subjects_affected="63" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="31" subjects_affected="29" subjects_at_risk="309"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="153" subjects_affected="124" subjects_at_risk="309"/>
                <counts group_id="E2" events="32" subjects_affected="31" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="28" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="26" subjects_affected="23" subjects_at_risk="309"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="38" subjects_affected="33" subjects_at_risk="309"/>
                <counts group_id="E2" events="47" subjects_affected="41" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="182" subjects_affected="99" subjects_at_risk="309"/>
                <counts group_id="E2" events="56" subjects_affected="36" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="110" subjects_affected="65" subjects_at_risk="309"/>
                <counts group_id="E2" events="74" subjects_affected="40" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="64" subjects_affected="48" subjects_at_risk="309"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="51" subjects_affected="32" subjects_at_risk="309"/>
                <counts group_id="E2" events="25" subjects_affected="16" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="77" subjects_affected="53" subjects_at_risk="309"/>
                <counts group_id="E2" events="34" subjects_affected="31" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="21" subjects_affected="18" subjects_at_risk="309"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="55" subjects_affected="43" subjects_at_risk="309"/>
                <counts group_id="E2" events="36" subjects_affected="33" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="35" subjects_affected="25" subjects_at_risk="309"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="36" subjects_affected="29" subjects_at_risk="309"/>
                <counts group_id="E2" events="36" subjects_affected="28" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="309"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="30" subjects_affected="23" subjects_at_risk="309"/>
                <counts group_id="E2" events="19" subjects_affected="15" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="66" subjects_affected="53" subjects_at_risk="309"/>
                <counts group_id="E2" events="35" subjects_affected="28" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="32" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="72" subjects_affected="52" subjects_at_risk="309"/>
                <counts group_id="E2" events="37" subjects_affected="28" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="309"/>
                <counts group_id="E2" events="24" subjects_affected="17" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="24" subjects_affected="21" subjects_at_risk="309"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="26" subjects_at_risk="309"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="31" subjects_at_risk="309"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="86" subjects_affected="74" subjects_at_risk="309"/>
                <counts group_id="E2" events="27" subjects_affected="25" subjects_at_risk="312"/>
              </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="88" subjects_affected="76" subjects_at_risk="309"/>
                <counts group_id="E2" events="52" subjects_affected="48" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="22" subjects_at_risk="309"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="34" subjects_affected="30" subjects_at_risk="309"/>
                <counts group_id="E2" events="23" subjects_affected="19" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="20" subjects_at_risk="309"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="25" subjects_affected="21" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="48" subjects_affected="37" subjects_at_risk="309"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="45" subjects_affected="36" subjects_at_risk="309"/>
                <counts group_id="E2" events="39" subjects_affected="29" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="25" subjects_affected="23" subjects_at_risk="309"/>
                <counts group_id="E2" events="28" subjects_affected="25" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="23" subjects_affected="20" subjects_at_risk="309"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="309"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="39" subjects_affected="28" subjects_at_risk="309"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="309"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="29" subjects_affected="22" subjects_at_risk="309"/>
                <counts group_id="E2" events="19" subjects_affected="15" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="157" subjects_affected="99" subjects_at_risk="309"/>
                <counts group_id="E2" events="48" subjects_affected="34" subjects_at_risk="312"/>
              </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="30" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="22" subjects_affected="21" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="25" subjects_at_risk="309"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="309"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="309"/>
                <counts group_id="E2" events="34" subjects_affected="25" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="34" subjects_affected="32" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="35" subjects_affected="27" subjects_at_risk="309"/>
                <counts group_id="E2" events="28" subjects_affected="24" subjects_at_risk="312"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="51" subjects_affected="39" subjects_at_risk="309"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="312"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="144" subjects_affected="121" subjects_at_risk="309"/>
                <counts group_id="E2" events="49" subjects_affected="44" subjects_at_risk="312"/>
              </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 Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme LLC</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT03829332
org study id: 7902-007
secondary id: MK-7902-007
secondary id: E7080-G000-314
secondary id: LEAP-007
secondary id: 194670
secondary id: 2018-003794-98
nct id: NCT03829332
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475)
      combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for
      lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic
      non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1)
      Tumor Proportion Score (TPS) greater than or equal to 1%.

      The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is
      superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response
      Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of
      pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall
      Survival (OS).
As of 30-Jul-2021, active participants, investigator, and sponsor personnel or delegate(s)
      involved in the treatment administration or clinical evaluation of the participants will be
      unblinded. Participants will discontinue lenvatinib and placebo, and participants who remain
      on treatment will receive open-label pembrolizumab only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 25 months
description: PFS was defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Data are from the product-limit (Kaplan-Meier) method for censored data. PFS as assessed by blinded independent central review (BICR) per RECIST 1.1 is presented.
measure: Overall Survival (OS)
time frame: Up to approximately 25 months
description: OS was defined as the time from date of randomization to date of death from any cause. OS is presented.
measure: Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
time frame: Up to approximately 25 months
description: ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR as assessed by BICR per RECIST 1.1 is presented.
measure: Number of Participants Who Experience an Adverse Event (AE)
time frame: Through 90 days post last dose of study treatment (Up to approximately 27 months)
description: An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
time frame: Through last dose of study treatment (Up to approximately 24 months)
description: The number of participants who discontinue study treatment due to an AE will be presented.
measure: Change From Baseline in Global Health Status (GHS) (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] Item 29) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) score will be presented. A higher score indicates a better overall GHS.
measure: Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question " How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in QoL (EORTC QLQ-C30 Item 30) score will be presented. A higher score indicates a better overall QoL.
measure: Change From Baseline in Cough (EORTC Quality of Life Questionnaire-Lung Cancer Module 13 [QLQ-LC13] Item 31) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in cough (EORTC QLQ-LC13 Item 31) score will be presented. A lower score indicates a better outcome.
measure: Change From Baseline in Chest Pain (EORTC QLQ-LC13 Item 40) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
measure: Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented. A lower score indicates a better outcome.
measure: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented. A higher score indicates a better quality of life.
measure: Time to True Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS) (EORTC QLQ-C30 Item 29) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
measure: Time to True Deterioration (TTD) Based on Change From Baseline in Quality of Life (QoL) (EORTC QLQ-C30 Item 30) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in QoL (EORTC QLQ-C30 Item 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in QoL score, will be presented. A longer TTD indicates a better outcome.
measure: Time to True Deterioration (TTD) Based on Change From Baseline in the Composite Endpoint of Cough (EORTC QLQ-LC13 Item 31), Chest Pain (EORTC QLQ-LC13 Item 40), or Dyspnea (EORTC QLQ-C30 Item 8)
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough (QLQ-LC13 item 31), chest pain (QLQ-LC13 item 40), or dyspnea (QLQ-C30 Item 8). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in the composite endpoint of cough, chest pain or dyspnea, will be presented. A longer TTD indicates a better outcome.
measure: Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
time frame: Baseline (Cycle 1 Day 1: Predose) and at designated timepoints (Predose) up to 30 days post last dose. Each cycle is 21 days. (Up to approximately 25 months)
description: TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in physical functioning score, will be presented.
arm group label: Pembrolizumab + Lenvatinib
arm group type: Experimental
description: Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS lenvatinib 20 mg via oral capsule once daily (QD) on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
arm group label: Pembrolizumab + Placebo
arm group type: Active Comparator
description: Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS placebo for lenvatinib via oral capsule QD on Days 1-21 of each 3-week cycle until progressive disease or unacceptable toxicity.
intervention type: Biological
intervention name: Pembrolizumab
description: IV infusion
arm group label: Pembrolizumab + Lenvatinib
arm group label: Pembrolizumab + Placebo
other name: MK-3475
other name: KEYTRUDA®
intervention type: Drug
intervention name: Lenvatinib
description: oral capsule
arm group label: Pembrolizumab + Lenvatinib
other name: MK-7902
other name: E7080
other name: LENVIMA®
intervention type: Drug
intervention name: Placebo for lenvatinib
description: oral capsule
arm group label: Pembrolizumab + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
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country: Australia
country: Canada
country: China
country: Colombia
country: Estonia
country: France
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Malaysia
country: Mexico
country: Poland
country: Russian Federation
country: Taiwan
country: Turkey
country: Ukraine
country: United States
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trial Information
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pembrolizumab
mesh term: Lenvatinib
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 