<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/NCT03302234</url>
  </required_header>
  <id_info>
    <org_study_id>3475-598</org_study_id>
    <secondary_id>MK-3475-598</secondary_id>
    <secondary_id>KEYNOTE-598</secondary_id>
    <secondary_id>2016-004364-20</secondary_id>
    <nct_id>NCT03302234</nct_id>
  </id_info>
  <brief_title>Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) (KEYNOTE-598)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 determine the efficacy of pembrolizumab given in combination&#xD;
      with either ipilimumab or placebo as first-line treatment in participants with metastatic&#xD;
      non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall&#xD;
      survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive&#xD;
      pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.&#xD;
&#xD;
      With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and&#xD;
      sponsor personnel or delegate(s) involved in the treatment administration or clinical&#xD;
      evaluation of the participants will be unblinded. Participants will discontinue ipilimumab&#xD;
      and placebo and participants who remain on treatment will receive open-label pembrolizumab&#xD;
      only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2017</start_date>
  <completion_date type="Actual">September 7, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 32 months (through data cut-off date: 01 Sep 2020)</time_frame>
    <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. 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 predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)</measure>
    <time_frame>Up to approximately 32 months (through data cut-off date 01 Sep 2020)</time_frame>
    <description>PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR</measure>
    <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
    <description>ORR was defined as the percentage of participants 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 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the 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 predominant tumor history (squamous versus non-squamous) for the first course of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Per RECIST 1.1 Based on BICR</measure>
    <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
    <description>For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath</measure>
    <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
    <description>TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced an Adverse Event (AE)</measure>
    <time_frame>Up to approximately 27 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Treatment Due to an AE</measure>
    <time_frame>Up to approximately 24 months</time_frame>
    <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18</measure>
    <time_frame>Baseline, Week 18</time_frame>
    <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions &quot;How would you rate your overall health during the past week?&quot; and &quot;How would you rate your overall quality of life during the past week?&quot; were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">568</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Pembrolizumab + Ipilimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pembrolizumab + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Administered as an intravenous (IV) infusion every 3 weeks (Q3W)</description>
    <arm_group_label>Pembrolizumab + Ipilimumab</arm_group_label>
    <arm_group_label>Pembrolizumab + Placebo</arm_group_label>
    <other_name>KEYTRUDA®</other_name>
    <other_name>MK-3475</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Administered as an IV infusion every 6 weeks (Q6W)</description>
    <arm_group_label>Pembrolizumab + Ipilimumab</arm_group_label>
    <other_name>YERVOY®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Normal saline solution administered as an IV infusion Q6W</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 Stage IV metastatic&#xD;
             non-small cell lung cancer (NSCLC) (American Joint Committee on Cancer version 8)&#xD;
&#xD;
          -  Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1&#xD;
             (RECIST 1.1) as determined by investigator&#xD;
&#xD;
          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  Has a life expectancy of at least 3 months&#xD;
&#xD;
          -  Has provided archival tumor tissue sample or newly obtained core or excisional biopsy&#xD;
             of a tumor lesion not previously irradiated&#xD;
&#xD;
          -  Female participants of childbearing potential must have a negative serum pregnancy&#xD;
             test within 72 hours prior to receiving the first dose of study therapy&#xD;
&#xD;
          -  Female participants of reproductive potential must agree to use contraception starting&#xD;
             from the first dose of study medication, throughout the study period, and for up to&#xD;
             120 days after the last dose of study medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received prior systemic chemotherapy/other targeted or biological antineoplastic&#xD;
             therapy treatment for their Stage IV metastatic NSCLC&#xD;
&#xD;
          -  Has a tumor that harbors an epidermal growth factor receptor (EGFR)-sensitizing&#xD;
             (activating) mutation or an anaplastic lymphoma kinase (ALK) translocation&#xD;
&#xD;
          -  Is currently participating in or has participated in a trial of an investigational&#xD;
             agent or has used an investigational device within 4 weeks prior to the first dose of&#xD;
             study therapy&#xD;
&#xD;
          -  Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1),&#xD;
             anti-Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti- Programmed Cell&#xD;
             Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory&#xD;
             or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4&#xD;
             [CTLA-4], OX-40, CD137)&#xD;
&#xD;
          -  Has received prior radiotherapy within 2 weeks of start of study therapy or received&#xD;
             lung radiation therapy of &gt;30 Gray (Gy) within 6 months of the first dose of study&#xD;
             therapy&#xD;
&#xD;
          -  Has recovered from all radiation-related toxicities, does not require corticosteroids,&#xD;
             and has not had radiation pneumonitis&#xD;
&#xD;
          -  Is receiving systemic steroid therapy ≤7 days prior to the first dose of study therapy&#xD;
             or receiving any other form of immunosuppressive medication&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or has required active treatment&#xD;
             within the past 3 years with the exception of curatively treated basal cell carcinoma&#xD;
             of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ&#xD;
             cancers&#xD;
&#xD;
          -  Has known untreated central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis&#xD;
&#xD;
          -  Has an active autoimmune disease that has required systemic treatment in past 2 years&#xD;
             (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive&#xD;
             drugs)&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
             (i.e., doses exceeding 10 mg daily of prednisone equivalent) or any other form of&#xD;
             immunosuppressive therapy within 7 days prior the first dose of study therapy&#xD;
&#xD;
          -  Has a history of (non-infectious) pneumonitis that required systemic steroids or&#xD;
             current pneumonitis/interstitial lung disease&#xD;
&#xD;
          -  Has had an allogeneic tissue/solid organ transplant&#xD;
&#xD;
          -  Has received a live vaccine within 30 days prior to the first dose of study therapy&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy&#xD;
&#xD;
          -  Has a known history of human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Has a known history of hepatitis B or known active hepatitis C virus infection&#xD;
&#xD;
          -  Has a known history of active tuberculosis&#xD;
&#xD;
          -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperating with the requirements of the trial&#xD;
&#xD;
          -  Is a regular user of any illicit drugs or had a recent history of substance abuse&#xD;
&#xD;
          -  Is pregnant or breast feeding or expecting to conceive starting from the first dose of&#xD;
             study medication, throughout the study period, and for up to 120 days after the last&#xD;
             dose of study medication&#xD;
&#xD;
          -  Has severe hypersensitivity to pembrolizumab and/or any of its excipients and/or to&#xD;
             ipilimumab and/or any of its excipients&#xD;
&#xD;
          -  Has a c-ros oncogene 1 (ROS1) mutation&#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>Mayo Clinic Cancer Center ( Site 0007)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Disney Family Cancer Center ( Site 0035)</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Cancer Care ( Site 0001)</name>
      <address>
        <city>Monterey</city>
        <state>California</state>
        <zip>93940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute ( Site 0021)</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Cancer Institute ( Site 0009)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health-Paducah Medical Oncology and Hematology ( Site 0018)</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Cancer Specialists ( Site 0019)</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center ( Site 0025)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Hospital &amp; Medical Center ( Site 0020)</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Name Medical Center ( Site 0022)</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai ( Site 0034)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center ( Site 0016)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Ohio Oncology/Hematology Inc. ( Site 0003)</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Cancer Institute, Franz Clinic - Eastside ( Site 0031)</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greenville Health System ( Site 8010)</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Erlanger Oncology &amp; Hematology ( Site 0026)</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Cancer Specialists ( Site 0017)</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Arlington South ( Site 8006)</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Methodist Dallas Cancer Center ( Site 8000)</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Flower Mound ( Site 8007)</name>
      <address>
        <city>Flower Mound</city>
        <state>Texas</state>
        <zip>75028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Longview Cancer Center ( Site 8009)</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists, P.C. ( Site 8001)</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Memorial- North Star Lodge Cancer Center ( Site 0033)</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center ( Site 0004)</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin Clinical Cancer Center ( Site 0027)</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0202)</name>
      <address>
        <city>Viedma</city>
        <state>Rio Negro</state>
        <zip>R8500ACE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Parque ( Site 0201)</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DSV</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Aleman ( Site 0208)</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado Centro Medico Cordoba ( Site 0206)</name>
      <address>
        <city>Cordoba</city>
        <zip>X5016KEH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Oncologico Riojano Integral ( Site 0203)</name>
      <address>
        <city>La Rioja</city>
        <zip>F5300COE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Britanico ( Site 0205)</name>
      <address>
        <city>Rosario</city>
        <zip>S2000CVB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Oncologia de Rosario ( Site 0200)</name>
      <address>
        <city>Rosario</city>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico San Roque ( Site 0207)</name>
      <address>
        <city>Tucuman</city>
        <zip>T4000IAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Cancer Care Centre ( Site 2102)</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital ( Site 2105)</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chris OBrien Lifehouse ( Site 2100)</name>
      <address>
        <city>Camperdown</city>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Townsville Hospital ( Site 2103)</name>
      <address>
        <city>Douglas</city>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincents Hospital Melbourne ( Site 2101)</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0302)</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50070-550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Hematologia e Oncologia Viver Ltda ( Site 0305)</name>
      <address>
        <city>Santa Maria</city>
        <state>Rio Grande Do Sul</state>
        <zip>97015-513</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nossa Senhora da Conceicao ( Site 0306)</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>91350-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Cancer de Sao Paulo - ICESP ( Site 0300)</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz ( Site 0311)</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01323-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Escola Paulista de Medicina - UNIFESP ( Site 0304)</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0312)</name>
      <address>
        <city>Barretos</city>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEPON Centro de Pesquisa Oncológicas ( Site 0307)</name>
      <address>
        <city>Florianopolis</city>
        <zip>88034-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Servidor Publico do Estado ( Site 0308)</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04039-004</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre ( Site 0119)</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba ( Site 0106)</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS du Saguenay-Lac-St-Jean ( Site 0115)</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 5H6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISSS de la Monteregie-Centre ( Site 0100)</name>
      <address>
        <city>Greenfield Park</city>
        <state>Quebec</state>
        <zip>J4V 2H1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISSS-CA Hotel-Dieu de Levis ( Site 0108)</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <zip>G6V 3Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0107)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Jerome Medical Research Inc ( Site 0113)</name>
      <address>
        <city>St-Jerome</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad Catolica del Maule ( Site 0413)</name>
      <address>
        <city>Talca</city>
        <state>El Maule</state>
        <zip>3465584</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soc. Prosalud Montes y Orlandi Ltda (Orlandi Oncologia) ( Site 0401)</name>
      <address>
        <city>Santiago</city>
        <zip>7500006</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontificia Universidad Catolica de Chile ( Site 0404)</name>
      <address>
        <city>Santiago</city>
        <zip>8330032</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional del Cancer ( Site 0406)</name>
      <address>
        <city>Santiago</city>
        <zip>8380455</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Vina del Mar ( Site 0400)</name>
      <address>
        <city>Vina del Mar</city>
        <zip>2520000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe ( Site 0505)</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Clinica del Country ( Site 0500)</name>
      <address>
        <city>Bogota</city>
        <zip>110221</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0506)</name>
      <address>
        <city>Bogota</city>
        <zip>110311</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncomedica S.A. ( Site 0502)</name>
      <address>
        <city>Monteria</city>
        <zip>230002</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Cancerologico de Narino Ltda ( Site 0504)</name>
      <address>
        <city>Pasto</city>
        <zip>520001</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord du Marseille ( Site 0808)</name>
      <address>
        <city>Marseille</city>
        <state>Cedex 20</state>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie ( Site 0803)</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest. Hopital Morvan ( Site 0800)</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hopitalier Intercommunal Creteil ( Site 0802)</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Le Mans ( Site 0804)</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.R.U de Lille - Hopital Calmette ( Site 0805)</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon ( Site 0810)</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvel Hopital Civil ( Site 0809)</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse - Hopital Larrey ( Site 0801)</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelische Lungenklinik Berlin ( Site 0903)</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Klinikum Spandau ( Site 0910)</name>
      <address>
        <city>Berlin</city>
        <zip>13585</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Emil von Behring ( Site 0905)</name>
      <address>
        <city>Berlin</city>
        <zip>14165</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRH Waldklinikum Gera GmbH ( Site 0907)</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LungenClinic Grosshansdorf GmbH ( Site 0908)</name>
      <address>
        <city>Grosshansdorf</city>
        <zip>22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Heidelberg ( Site 0900)</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig ( Site 0919)</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig Holstein. ( Site 0918)</name>
      <address>
        <city>Luebeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1502)</name>
      <address>
        <city>Budapest</city>
        <zip>1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 1506)</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Onkologiai Intezet ( Site 1509)</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont ( Site 1511)</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veszprem Megyei Tudogyogyintezet ( Site 1503)</name>
      <address>
        <city>Farkasgyepu</city>
        <zip>8582</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petz Aladar Megyei Oktato Korhaz ( Site 1505)</name>
      <address>
        <city>Gyor</city>
        <zip>9024</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Pandy Kalman Korhaz. ( Site 1507)</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 1504)</name>
      <address>
        <city>Szekesfehervar</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1501)</name>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital ( Site 1312)</name>
      <address>
        <city>Dublin</city>
        <zip>D09 V2N0</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital ( Site 1401)</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Limerick ( Site 1403)</name>
      <address>
        <city>Limerick</city>
        <zip>V94 F858</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Casa Sollievo della Sofferenza ( Site 1009)</name>
      <address>
        <city>San Giovanni Rotondo (FG)</city>
        <state>Foggia</state>
        <zip>71013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Research Hospital ( Site 1004)</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mater Salutis ( Site 1005)</name>
      <address>
        <city>Legnago</city>
        <state>Verona</state>
        <zip>37045</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Spedali Civili ( Site 1001)</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia ( Site 1007)</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Gerardo ASST Monza ( Site 1002)</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AORN dei Colli Plesso Monaldi ( Site 1003)</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria della Misericordia ( Site 1008)</name>
      <address>
        <city>Perugia</city>
        <zip>06132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital ( Site 2303)</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System ( Site 2300)</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center ( Site 2302)</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center ( Site 2301)</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pauls Stradins Clinical University Hospital ( Site 1100)</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga East Clinical University Hospital ( Site 1111)</name>
      <address>
        <city>Riga</city>
        <zip>1079</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0603)</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avix Investigacion Clinica S.C. ( Site 0600)</name>
      <address>
        <city>Monterrey</city>
        <state>N.l.</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Care and Research S.A. de C.V. ( Site 0602)</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupo Medico Camino SC ( Site 0607)</name>
      <address>
        <city>Ciudad de Mexico</city>
        <zip>03310</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medica Sur S.A.B de C.V. ( Site 0608)</name>
      <address>
        <city>Mexico City</city>
        <zip>14050</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncologica de Puebla SA de CV ( Site 0606)</name>
      <address>
        <city>Puebla</city>
        <zip>72530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Guillermo Almenara Irigoyen ( Site 0705)</name>
      <address>
        <city>La Victoria</city>
        <state>Lima</state>
        <zip>15033</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Especializado de Enfermedades Neoplasicas SRL-CEEN SRL ( Site 0710)</name>
      <address>
        <city>Arequipa</city>
        <zip>04000</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 0704)</name>
      <address>
        <city>Arequipa</city>
        <zip>04000</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Internacional Sede San Borja ( Site 0701)</name>
      <address>
        <city>Lima</city>
        <zip>15036</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Cayetano Heredia ( Site 0706)</name>
      <address>
        <city>Lima</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Peruano Americana S.A. ( Site 0703)</name>
      <address>
        <city>Trujillo</city>
        <zip>13007</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dolnoslaskie Centrum Onkologii. ( Site 1616)</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>53-413</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 1614)</name>
      <address>
        <city>Koszalin</city>
        <state>Zachodniopomorskie</state>
        <zip>75-581</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Powiatowe Centrum Zdrowia w Brzezinach ( Site 1615)</name>
      <address>
        <city>Brzeziny</city>
        <zip>95-060</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1609)</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia Lekarska Komed ( Site 1602)</name>
      <address>
        <city>Konin</city>
        <zip>62-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc ( Site 1607)</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-357</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MED-POLONIA Sp. z o.o. ( Site 1605)</name>
      <address>
        <city>Poznan</city>
        <zip>60-693</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie ( Site 1600)</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitas Annex National Hospital ( Site 1800)</name>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinton Onclogy Clinic ( Site 1804)</name>
      <address>
        <city>Alberton</city>
        <state>Gauteng</state>
        <zip>1448</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilgers Oncology Centre ( Site 1808)</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0081</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vincent Pallotti Hospital ( Site 1811)</name>
      <address>
        <city>Cape Town</city>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Stellenbosch and Tygerberg Hospital ( Site 1810)</name>
      <address>
        <city>Cape Town</city>
        <zip>8000</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr G.A. Landers Specialist Oncologist ( Site 1803)</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Maxeke Johannesburg Academic Hospital ( Site 1806)</name>
      <address>
        <city>Johannesburg</city>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sandton Oncology Medical Group PTY LTD ( Site 1807)</name>
      <address>
        <city>Johannesburg</city>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GVI Oncology Clinical Research Centre ( Site 1802)</name>
      <address>
        <city>Kraaifontein</city>
        <zip>7570</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Germans Trias i Pujol ( Site 1207)</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Duran i Reynals ( Site 1201)</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcantara ( Site 1208)</name>
      <address>
        <city>Caceres</city>
        <state>Extremadura</state>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Insular de Gran Canaria ( Site 1203)</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Gran Canaria</state>
        <zip>35001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d Hebron ( Site 1211)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Fundacion Jimenez Diaz - Clin. Concepcion ( Site 1209)</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio ( Site 1200)</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital ( Site 2406)</name>
      <address>
        <city>Changhua</city>
        <zip>50006</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation - Kaohsiung ( Site 2404)</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital ( Site 2403)</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital ( Site 2401)</name>
      <address>
        <city>Tainan</city>
        <zip>70457</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital ( Site 2400)</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mackay Memorial Hospital ( Site 2405)</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital - Linkou Branch ( Site 2402)</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramathibodi Hospital. ( Site 2563)</name>
      <address>
        <city>Ratchthevee</city>
        <state>Bangkok</state>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bangkok Hospital Chiangmai ( Site 2560)</name>
      <address>
        <city>Mueang</city>
        <state>Chiang Mai</state>
        <zip>50000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chulalongkorn Hospital ( Site 2561)</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pramongkutklao Hospital ( Site 2564)</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital ( Site 2562)</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khon Kaen University ( Site 2565)</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem Adana Hastanesi ( Site 1904)</name>
      <address>
        <city>Adana</city>
        <zip>01130</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1908)</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uludag Universitesi Tip Fakultesi ( Site 1914)</name>
      <address>
        <city>Bursa</city>
        <zip>16059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Sehir Hastanesi ( Site 1903)</name>
      <address>
        <city>Cankaya - Ankara</city>
        <zip>06490</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trakya Uni. Tip Fakultesi ( Site 1911)</name>
      <address>
        <city>Edirne</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1906)</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 1912)</name>
      <address>
        <city>Istanbul</city>
        <zip>34899</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Universitesi Tip Fakultesi Hastanesi ( Site 1901)</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Park Izmir Hospital ( Site 1900)</name>
      <address>
        <city>Izmir</city>
        <zip>35575</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kocaeli Universitesi Tip Fakultesi ( Site 1909)</name>
      <address>
        <city>Kocaeli</city>
        <zip>41380</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu Universitesi Tip Fakultesi ( Site 1907)</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karadeniz Teknik Universitesi ( Site 1910)</name>
      <address>
        <city>Trabzon</city>
        <zip>61080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2005)</name>
      <address>
        <city>Kryviy Rih</city>
        <state>Dnipropetrovsk Region</state>
        <zip>50048</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cherkasy Regional Hospital ( Site 2020)</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Clinical Onco Dispensary_ State Medical University ( Site 2012)</name>
      <address>
        <city>Chernivtsy</city>
        <zip>58013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnipropetrovsk City Multidiscipline Clinical Hosp.4 of DRC ( Site 2000)</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Prykarpatskyi Clinical Oncology Centrum ( Site 2009)</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PP PPC Acinus Medical and Diagnostic Centre ( Site 2002)</name>
      <address>
        <city>Kropyvnytskyi</city>
        <zip>25006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute of the MoH of Ukraine ( Site 2015)</name>
      <address>
        <city>Kyiv</city>
        <zip>03002</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv City Clinical Oncological Center ( Site 2014)</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2003)</name>
      <address>
        <city>Lviv</city>
        <zip>79031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI Odessa Regional Oncological Centre ( Site 2004)</name>
      <address>
        <city>Odesa</city>
        <zip>65055</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospital ( Site 1325)</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust. ( Site 1326)</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belfast City Hospital ( Site 1302)</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Free NHS Foundation Trust ( Site 1324)</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Georges University Hospital NHS Foundation Trust ( Site 1321)</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust.. ( Site 1327)</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust ( Site 1301)</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Vernon Cancer Centre ( Site 1307)</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Wolverhampton Hospitals NHS Trust ( Site 1323)</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Russian Federation</country>
  </removed_countries>
  <link>
    <url>http://merckoncologyclinicaltrials.com</url>
    <description>Merck Oncology Clinical Trials Information</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <results_first_submitted>August 12, 2021</results_first_submitted>
  <results_first_submitted_qc>September 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2021</results_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Programmed Cell Death Receptor 1 (PD-1)</keyword>
  <keyword>Programmed Cell Death Receptor Ligand 1 (PD-L1)</keyword>
  <keyword>Cytotoxic T-lymphocyte-associated protein 4 (CTLA4)</keyword>
  <keyword>PD1</keyword>
  <keyword>PD-1</keyword>
  <keyword>PDL1</keyword>
  <keyword>PD-L1</keyword>
  <keyword>CTLA4</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Ipilimumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd</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>December 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03302234/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of 568 participants randomized to the study, 563 received at least one dose of study treatment (All Treated Population) and were evaluable for all safety analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pembrolizumab + Ipilimumab</title>
          <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
        </group>
        <group group_id="P2">
          <title>Pembrolizumab + Placebo</title>
          <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="284"/>
                <participants group_id="P2" count="284"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="146"/>
                <participants group_id="P2" count="147"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="138"/>
                <participants group_id="P2" count="137"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <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="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Laryngeal carcinoma</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Pembrolizumab + Ipilimumab</title>
          <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
        </group>
        <group group_id="B2">
          <title>Pembrolizumab + Placebo</title>
          <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</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="284"/>
            <count group_id="B2" value="284"/>
            <count group_id="B3" value="568"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.7" spread="9.3"/>
                    <measurement group_id="B2" value="64.5" spread="8.8"/>
                    <measurement group_id="B3" value="64.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B2" value="191"/>
                    <measurement group_id="B3" value="393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Undifferentiated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <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="54"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="433"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="64"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="441"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) performance status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0 = Fully active; no performance restrictions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 = Strenuous physical activity restricted; fully ambulatory &amp; able to carry out light work</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="183"/>
                    <measurement group_id="B2" value="180"/>
                    <measurement group_id="B3" value="363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor histology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Squamous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non squamous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="207"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Geographic region</title>
          <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="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-East Asia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="253"/>
                    <measurement group_id="B3" value="505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. 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 predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.</description>
        <time_frame>Up to approximately 32 months (through data cut-off date: 01 Sep 2020)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. 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 predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.</description>
          <population>All randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="284"/>
                <count group_id="O2" value="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="16.6" upper_limit="NA">NA = Upper limit OS was not reached at the time of last disease assessment due to insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="21.9" lower_limit="18.0" upper_limit="NA">NA = Upper limit OS was not reached at the time of last disease assessment due to insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.74156</p_value>
            <p_value_desc>One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)</title>
        <description>PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.</description>
        <time_frame>Up to approximately 32 months (through data cut-off date 01 Sep 2020)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)</title>
          <description>PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.</description>
          <population>All randomized participants</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="284"/>
                <count group_id="O2" value="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="6.0" upper_limit="10.5"/>
                    <measurement group_id="O2" value="8.4" lower_limit="6.3" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.71720</p_value>
            <method>Log Rank</method>
            <method_desc>One-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor history.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.30</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site and predominant tumor history.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR</title>
        <description>ORR was defined as the percentage of participants 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 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the 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 predominant tumor history (squamous versus non-squamous) for the first course of study treatment.</description>
        <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
        <population>All randomized participants</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR</title>
          <description>ORR was defined as the percentage of participants 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 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the 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 predominant tumor history (squamous versus non-squamous) for the first course of study treatment.</description>
          <population>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="284"/>
                <count group_id="O2" value="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.4" lower_limit="39.5" upper_limit="51.4"/>
                    <measurement group_id="O2" value="45.4" lower_limit="39.5" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.50644</p_value>
            <method>Miettinen &amp; Nurminen method</method>
            <method_desc>One-sided p-value for testing</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>-0.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.2</ci_lower_limit>
            <ci_upper_limit>8.1</ci_upper_limit>
            <estimate_desc>Based on Miettinen &amp; Nurminen method stratified by ECOG, geographic region of the enrolling site and predominant tumor history.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Per RECIST 1.1 Based on BICR</title>
        <description>For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.</description>
        <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
        <population>All randomized participants with confirmed complete response or partial response</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Per RECIST 1.1 Based on BICR</title>
          <description>For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.</description>
          <population>All randomized participants with confirmed complete response or partial response</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="129"/>
                <count group_id="O2" value="129"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" lower_limit="12.7" upper_limit="26"/>
                    <measurement group_id="O2" value="17.3" lower_limit="14.8" upper_limit="NA">NA = DOR 95%CI upper limit not reached at the time of last disease assessment due to insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath</title>
        <description>TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.</description>
        <time_frame>Up to approximately 32 months (data cut-off date 01 Sep 2020)</time_frame>
        <population>All participants randomized who received at least one dose of study treatment and had at least one EORTC QLQ-LC13 and EORTC QLQ-C30 available.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath</title>
          <description>TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.</description>
          <population>All participants randomized who received at least one dose of study treatment and had at least one EORTC QLQ-LC13 and EORTC QLQ-C30 available.</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="268"/>
                <count group_id="O2" value="270"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="12.9778" upper_limit="NA">NA = Median TTD and upper limit for TTD was not reached at the time of last disease assessment due to insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="20.0416" lower_limit="12.7149" upper_limit="NA">NA = Upper limit for TTD was not reached at the time of last disease assessment due to insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9112</p_value>
            <method>Log Rank</method>
            <method_desc>Two-sided p-value based on log-rank test stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.9815</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7386</ci_lower_limit>
            <ci_upper_limit>1.3042</ci_upper_limit>
            <estimate_desc>Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, geographic region of the enrolling site, and predominant tumor histology.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
        <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.</description>
        <time_frame>Up to approximately 27 months</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced an Adverse Event (AE)</title>
          <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="282"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272"/>
                    <measurement group_id="O2" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Study Treatment Due to an AE</title>
        <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.</description>
        <time_frame>Up to approximately 24 months</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Treatment Due to an AE</title>
          <description>An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="282"/>
                <count group_id="O2" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18</title>
        <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions &quot;How would you rate your overall health during the past week?&quot; and &quot;How would you rate your overall quality of life during the past week?&quot; were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.</description>
        <time_frame>Baseline, Week 18</time_frame>
        <population>All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment available.</population>
        <group_list>
          <group group_id="O1">
            <title>Pembrolizumab + Ipilimumab</title>
            <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
          <group group_id="O2">
            <title>Pembrolizumab + Placebo</title>
            <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18</title>
          <description>The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions &quot;How would you rate your overall health during the past week?&quot; and &quot;How would you rate your overall quality of life during the past week?&quot; were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.</description>
          <population>All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment available.</population>
          <units>Score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="279"/>
                <count group_id="O2" value="280"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.72" lower_limit="0.91" upper_limit="6.53"/>
                    <measurement group_id="O2" value="4.14" lower_limit="1.42" upper_limit="6.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8151</p_value>
            <method>cLDA Model</method>
            <method_desc>Constrained longitudinal data analysis (cLDA) Model</method_desc>
            <param_type>Difference in LS Means</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.96</ci_lower_limit>
            <ci_upper_limit>3.12</ci_upper_limit>
            <estimate_desc>Based on a cLDA model with PRO scores as response variable, with covariates for treatment by time interaction, and stratification factors (ECOG, geographic region of the enrolling site, &amp; predominant tumor histology) as covariates.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events (AEs), non-serious AEs and all-cause mortality was collected up to approximately 32 months for first and second course treatment through data cut-off date 01 Sep 2020.</time_frame>
      <desc>All-cause mortality was reported on all randomized participants (first and second course). Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. MedDRA preferred terms 'Neoplasm progression', 'Malignant neoplasm progression' and 'Disease progression' not related to the drug were excluded. Pembrolizumab + Ipilimumab (second course) was not reported since no participants were eligible for second course treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pembrolizumab + Ipilimumab (First Course)</title>
          <description>Participants received 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued ipilimumab and participants who remained on treatment received open-label pembrolizumab only. Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
        </group>
        <group group_id="E2">
          <title>Pembrolizumab + Placebo (First Course)</title>
          <description>Participants received 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment. Per Amendment (AM) 6, (effective date: 11-Dec-2020), participants discontinued placebo and participants who remained on treatment received open-label pembrolizumab only.</description>
        </group>
        <group group_id="E3">
          <title>Pembrolizumab + Placebo (Second Course)</title>
          <description>Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (~2 years) or who attained complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule at 200 mg IV on Day 1 each 3-week cycle (Q3W), for up to 17 cycles (up to ~1 year).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</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="137" subjects_at_risk="284"/>
                <counts group_id="E2" subjects_affected="135" subjects_at_risk="284"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="145" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="108" subjects_at_risk="281"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </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="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Autoimmune pericarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Adrenocortical insufficiency acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocytic hypophysitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ophthalmoplegia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrointestinal toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Immune-mediated enterocolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Salivary gland calculus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cholelithiasis migration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cholestatic liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion related hypersensitivity reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adrenalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diverticulitis intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="21" subjects_at_risk="282"/>
                <counts group_id="E2" events="22" subjects_affected="18" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis septic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ilium fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Eosinophilic fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vertebral lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ductal adenocarcinoma of pancreas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Infected neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Paraneoplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral sensorimotor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="3" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Autoimmune nephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="282"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Immune-mediated pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="282"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="282"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="282"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="282"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="249" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="231" subjects_at_risk="281"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
              </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="51" subjects_affected="40" subjects_at_risk="282"/>
                <counts group_id="E2" events="54" subjects_affected="39" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="282"/>
                <counts group_id="E2" events="23" subjects_affected="17" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="47" subjects_affected="43" subjects_at_risk="282"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="45" subjects_affected="39" subjects_at_risk="282"/>
                <counts group_id="E2" events="55" subjects_affected="50" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="101" subjects_affected="68" subjects_at_risk="282"/>
                <counts group_id="E2" events="68" subjects_affected="44" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="282"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="65" subjects_affected="49" subjects_at_risk="282"/>
                <counts group_id="E2" events="46" subjects_affected="38" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="43" subjects_affected="30" subjects_at_risk="282"/>
                <counts group_id="E2" events="33" subjects_affected="26" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="65" subjects_affected="51" subjects_at_risk="282"/>
                <counts group_id="E2" events="56" subjects_affected="43" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="282"/>
                <counts group_id="E2" events="29" subjects_affected="25" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="65" subjects_affected="47" subjects_at_risk="282"/>
                <counts group_id="E2" events="54" subjects_affected="47" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="28" subjects_affected="23" subjects_at_risk="282"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="39" subjects_affected="33" subjects_at_risk="282"/>
                <counts group_id="E2" events="33" subjects_affected="26" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="282"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="282"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="282"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="39" subjects_affected="35" subjects_at_risk="282"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="282"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="21" subjects_affected="15" subjects_at_risk="282"/>
                <counts group_id="E2" events="18" subjects_affected="15" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="30" subjects_affected="28" subjects_at_risk="282"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="71" subjects_affected="59" subjects_at_risk="282"/>
                <counts group_id="E2" events="43" subjects_affected="38" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="15" subjects_at_risk="282"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="282"/>
                <counts group_id="E2" events="29" subjects_affected="18" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="282"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="19" subjects_at_risk="282"/>
                <counts group_id="E2" events="24" subjects_affected="14" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="282"/>
                <counts group_id="E2" events="18" subjects_affected="14" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="32" subjects_affected="27" subjects_at_risk="282"/>
                <counts group_id="E2" events="39" subjects_affected="33" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="34" subjects_affected="29" subjects_at_risk="282"/>
                <counts group_id="E2" events="33" subjects_affected="28" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="282"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="282"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="282"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="282"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="17" subjects_at_risk="282"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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="55" subjects_affected="48" subjects_at_risk="282"/>
                <counts group_id="E2" events="75" subjects_affected="57" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="45" subjects_affected="41" subjects_at_risk="282"/>
                <counts group_id="E2" events="49" subjects_affected="42" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="282"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="282"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="282"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="97" subjects_affected="69" subjects_at_risk="282"/>
                <counts group_id="E2" events="74" subjects_affected="55" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="77" subjects_affected="55" subjects_at_risk="282"/>
                <counts group_id="E2" events="60" subjects_affected="42" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="28" subjects_affected="23" subjects_at_risk="282"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="281"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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 must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</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/NCT03302234
org study id: 3475-598
secondary id: MK-3475-598
secondary id: KEYNOTE-598
secondary id: 2016-004364-20
nct id: NCT03302234
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the efficacy of pembrolizumab given in combination
      with either ipilimumab or placebo as first-line treatment in participants with metastatic
      non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall
      survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive
      pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

      With Amendment 6 (effective date: 11-Dec-2020), 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 ipilimumab
      and placebo and participants who remain on treatment will receive open-label pembrolizumab
      only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Overall Survival (OS)
time frame: Up to approximately 32 months (through data cut-off date: 01 Sep 2020)
description: OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date of last known contact. The median survival (in months) and the associated 95% confidence intervals (CIs) were reported using Kaplan-Meier method was used. 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 predominant tumor history (squamous versus non-squamous) was used to estimate hazard ratio (HR) and 95% CIs for first course study treatment per protocol.
measure: Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)
time frame: Up to approximately 32 months (through data cut-off date 01 Sep 2020)
description: PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in sum of diameters of target lesions. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The median survival (in months) and associated 95% CIs were reported using Kaplan-Meier method. Cox regression model with Efron's method of tie handling with treatment as covariate stratified by ECOG performance status (0 vs. 1), geographic region of the enrolling site (East Asia vs. non-East Asia), and predominant tumor history (squamous vs. non-squamous) was used to estimate HR and 95% CIs for first course study treatment per protocol.
measure: Objective Response Rate (ORR) Per RECIST 1.1 Based on BICR
time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
description: ORR was defined as the percentage of participants 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 by BICR. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. Per protocol the ORR was calculated using the Miettinen & Nurminen method stratified by ECOG performance status (0 versus 1), geographic region of the enrolling site (East Asia versus non-East Asia), and predominant tumor history (squamous versus non-squamous) for the first course of study treatment.
measure: Duration of Response (DOR) Per RECIST 1.1 Based on BICR
time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
description: For participants who demonstrated a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. Per protocol, the DOR for all participants who experienced a CR or PR was presented for the first course of study treatment.
measure: Time to True Deterioration (TTD) in Cough, Pain in Chest, and Shortness of Breath
time frame: Up to approximately 32 months (data cut-off date 01 Sep 2020)
description: TTD was defined as the time to the first onset of a 10-point or greater score deterioration from baseline in any one of the 3 symptoms (cough, pain in chest or shortness of breath), confirmed by a second adjacent 10-point or greater score deterioration from baseline. Cough was based on EORTC QLQ-LC13 question 1, pain in chest was based on EORTC QLQ-LC13 question 10, and shortness of breath was based on EORTC QLQ-C30 question 8. Per protocol, TTD was reported for first course study treatment.
measure: Number of Participants Who Experienced an Adverse Event (AE)
time frame: Up to approximately 27 months
description: An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who experienced an AE were reported for the first course of study treatment and follow up.
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
time frame: Up to approximately 24 months
description: An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Per protocol, the number of participants who discontinued study treatment due to an AE were reported for the first course of study treatment.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score to Week 18
time frame: Baseline, Week 18
description: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. Per protocol, the change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score were presented for first course study treatment.
arm group label: Pembrolizumab + Ipilimumab
arm group type: Experimental
description: Participants receive 200 mg of pembrolizumab by intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus 1 mg/kg of ipilimumab by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
arm group label: Pembrolizumab + Placebo
arm group type: Active Comparator
description: Participants receive 200 mg of pembrolizumab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles of treatment plus placebo by IV infusion on Day 1 of each 6-week cycle for up to 18 cycles of treatment.
intervention type: Biological
intervention name: Pembrolizumab
description: Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
arm group label: Pembrolizumab + Ipilimumab
arm group label: Pembrolizumab + Placebo
other name: KEYTRUDA®
other name: MK-3475
intervention type: Biological
intervention name: Ipilimumab
description: Administered as an IV infusion every 6 weeks (Q6W)
arm group label: Pembrolizumab + Ipilimumab
other name: YERVOY®
intervention type: Other
intervention name: Placebo
description: Normal saline solution administered as an IV infusion Q6W
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: Argentina
country: Australia
country: Brazil
country: Canada
country: Chile
country: Colombia
country: France
country: Germany
country: Hungary
country: Ireland
country: Italy
country: Korea, Republic of
country: Latvia
country: Mexico
country: Peru
country: Poland
country: South Africa
country: Spain
country: Taiwan
country: Thailand
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Russian Federation
url: http://merckoncologyclinicaltrials.com
description: Merck Oncology Clinical Trials Information
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pembrolizumab
mesh term: Ipilimumab
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pd
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
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reported events: 
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point of contact: 