<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/NCT01708954</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2012-01938</org_study_id>
    <secondary_id>NCI-2012-01938</secondary_id>
    <secondary_id>ECOG-E1512</secondary_id>
    <secondary_id>CDR0000741879</secondary_id>
    <secondary_id>E1512</secondary_id>
    <secondary_id>E1512</secondary_id>
    <secondary_id>U10CA180820</secondary_id>
    <secondary_id>U10CA021115</secondary_id>
    <nct_id>NCT01708954</nct_id>
  </id_info>
  <brief_title>Erlotinib Hydrochloride and Cabozantinib-s-Malate Alone or in Combination as Second or Third Line Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer</brief_title>
  <official_title>A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase II trial studies how well giving erlotinib hydrochloride and&#xD;
      cabozantinib-s-malate alone or in combination works as second or third line therapy in&#xD;
      treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and&#xD;
      cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes&#xD;
      needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together&#xD;
      with cabozantinib-s-malate is more effective than erlotinib hydrochloride or&#xD;
      cabozantinib-s-malate alone in treating non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To compare the progression-free survival (PFS) associated with patients treated with&#xD;
      erlotinib (erlotinib hydrochloride) versus (vs) erlotinib plus cabozantinib&#xD;
      (cabozantinib-s-malate).&#xD;
&#xD;
      II. To compare the PFS associated with patients treated with erlotinib vs cabozantinib.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective&#xD;
      response rate in the three treatment arms. III. To define the toxicity associated with each&#xD;
      regimen. IV. To conduct correlative science studies that will help to select predictive&#xD;
      biomarkers of response to therapy, including mesenchymal-epidermal transition (MET)&#xD;
      expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 3 treatment arms.&#xD;
&#xD;
      ARM A (erlotinib): Patients receive erlotinib orally (PO) daily on days 1-28. Courses repeat&#xD;
      every 28 days in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM B (cabozantinib): Patients receive cabozantinib PO daily on days 1-28. Courses repeat&#xD;
      every 28 days in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM C (erlotinib+cabozantinib): Patients receive erlotinib as patients in Arm A and&#xD;
      cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and&#xD;
      cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for 2 years and&#xD;
      then every 6 months for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 13, 2013</start_date>
  <primary_completion_date type="Actual">August 14, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
    <description>PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
    <description>OS is defined as the time from randomization to death from any cause or date of last known alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Objective Response</measure>
    <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
    <description>Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With MET Positivity</measure>
    <time_frame>Assessed at baseline</time_frame>
    <description>Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher</measure>
    <time_frame>Assessed every 4 weeks while on treatment and for 30 days after the end of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Recurrent Lung Non-Small Cell Carcinoma</condition>
  <condition>Stage IV Lung Non-Small Cell Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Arm A (erlotinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (cabozantinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (erlotinib+cabozantinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Z (erlotinib+cabozantinib; step II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib S-malate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm B (cabozantinib)</arm_group_label>
    <arm_group_label>Arm C (erlotinib+cabozantinib)</arm_group_label>
    <arm_group_label>Arm Z (erlotinib+cabozantinib; step II)</arm_group_label>
    <other_name>BMS-907351</other_name>
    <other_name>Cabometyx</other_name>
    <other_name>Cometriq</other_name>
    <other_name>XL-184</other_name>
    <other_name>XL184</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib Hydrochloride</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (erlotinib)</arm_group_label>
    <arm_group_label>Arm C (erlotinib+cabozantinib)</arm_group_label>
    <arm_group_label>Arm Z (erlotinib+cabozantinib; step II)</arm_group_label>
    <other_name>Cp-358,774</other_name>
    <other_name>OSI-774</other_name>
    <other_name>Tarceva</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm A (erlotinib)</arm_group_label>
    <arm_group_label>Arm B (cabozantinib)</arm_group_label>
    <arm_group_label>Arm C (erlotinib+cabozantinib)</arm_group_label>
    <arm_group_label>Arm Z (erlotinib+cabozantinib; step II)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Criteria:&#xD;
&#xD;
          -  Tumor with a sensitizing mutation in epidermal growth factor receptor (EGFR), defined&#xD;
             as follows:&#xD;
&#xD;
               -  EGFR mutation testing of tumor has been performed and did not demonstrate an EGFR&#xD;
                  tyrosine kinase inhibitor sensitizing mutation; at minimum, testing for EGFR exon&#xD;
                  19 deletion and exon 21 L858R mutations must have been included; OR&#xD;
&#xD;
               -  EGFR mutation testing has been attempted and is inconclusive (for example, due to&#xD;
                  lack of sufficient deoxyribonucleic acid [DNA] yield); OR&#xD;
&#xD;
               -  EGFR mutation status is unknown but tumor is positive for at least one&#xD;
                  alternative driver mutation, i.e: Kirsten rat sarcoma viral oncogene homolog&#xD;
                  (KRAS) mutation, v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation,&#xD;
                  human epidermal growth factor receptor 2 (HER2) mutation, ret proto-oncogene&#xD;
                  (RET) rearrangement/fusion, or one not listed following approval by the study&#xD;
                  chair prior to registration&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  INCLUSION CRITERIA STEP 1:&#xD;
&#xD;
          -  Cytologically or histologically confirmed non-small cell lung carcinoma (NSCLC)&#xD;
&#xD;
          -  Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS]&#xD;
             are eligible); mixed tumors will be categorized by the predominant cell type; if small&#xD;
             cell elements are present the patient is ineligible&#xD;
&#xD;
          -  Stage IV disease (includes M1a, M1b, or recurrent disease), according to the 7th&#xD;
             edition of the lung cancer TNM classification system&#xD;
&#xD;
          -  Patients must have measurable disease as defined by Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) version (v) 1.1 criteria; baseline measurements and evaluation&#xD;
             of all sites of disease must be obtained within 4 weeks prior to registration&#xD;
&#xD;
          -  Prior to registration, the investigator/site must confirm that sufficient pathology&#xD;
             material representative of patient's cancer is available for submission for MET&#xD;
             immunohistochemical (IHC) testing&#xD;
&#xD;
          -  Patients must have received one or two lines of prior chemotherapy (first line&#xD;
             platinum-doublet based chemotherapy plus switch maintenance chemotherapy counts as one&#xD;
             line of therapy); prior adjuvant chemotherapy for early stage disease does not count&#xD;
             as one line of therapy if 12 months or greater elapsed between completion of adjuvant&#xD;
             therapy and initiation of first-line systemic therapy; if less than 12 months elapsed,&#xD;
             adjuvant chemotherapy counts as one line of therapy&#xD;
&#xD;
          -  Any prior chemotherapy (based on administration schedule) must have been completed in&#xD;
             greater than or equal to the time frames specified in the protocol&#xD;
&#xD;
          -  Patients must have discontinued treatment with any other type of investigational agent&#xD;
             &gt;= 4 weeks prior to registration&#xD;
&#xD;
          -  Patients must have recovered to baseline or Common Terminology Criteria for Adverse&#xD;
             Events (CTCAE) v 4.0 =&lt; grade 1 from toxicity due to all prior therapies except&#xD;
             alopecia and other non-clinically significant adverse events (AEs)&#xD;
&#xD;
          -  Patients with no known brain metastasis at baseline must have baseline brain imaging&#xD;
             within 12 weeks prior to study registration not demonstrating brain metastases;&#xD;
             patients with brain metastases at baseline must have baseline brain imagining within 4&#xD;
             weeks prior to study registration and meet all of the specific criteria for brain mets&#xD;
             listed in the protocol&#xD;
&#xD;
          -  Radiation related toxicities must have resolved to =&lt; grade 1 prior to registration&#xD;
&#xD;
          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
             between 0-2&#xD;
&#xD;
          -  Patients must have an anticipated life expectancy greater than 3 months&#xD;
&#xD;
          -  Acceptable bone marrow, renal and hepatic function within 2 weeks prior to&#xD;
             registration as defined in the protocol&#xD;
&#xD;
          -  Patients must have corrected QT interval calculated by the Fridericia formula (QTcF)&#xD;
             =&lt; 500 ms within 28 days before registration&#xD;
&#xD;
          -  Patients must be able to swallow tablets&#xD;
&#xD;
          -  INCLUSION CRITERIA STEP 2:&#xD;
&#xD;
          -  Patients must have met all eligibility requirements for Step 1 at time of registration&#xD;
             to Step 1 to be eligible for Step 2&#xD;
&#xD;
          -  Patients must have radiographic progressive disease per RECIST v1.1 criteria after &gt;=&#xD;
             2 courses of therapy on Arm A or Arm B&#xD;
&#xD;
          -  Patients must be registered to Step 2 within 4 weeks of the last dose of treatment&#xD;
             administration from Step 1&#xD;
&#xD;
          -  Patients must have an ECOG performance status between 0-2&#xD;
&#xD;
          -  Patients must have recovered to baseline (pre-Step 1) or CTCAE version 4.0 &lt;= grade 1&#xD;
             from toxicity due to all prior therapies except alopecia and other non-clinically&#xD;
             significant AEs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  EXCLUSION CRITERIA STEP 1:&#xD;
&#xD;
          -  Patients without sufficient pathology material representative of the patient's cancer&#xD;
             (tumor block or 10 unstained slides)&#xD;
&#xD;
          -  Prior erlotinib, other EGFR tyrosine kinase inhibitor therapy, vascular endothelial&#xD;
             growth factor receptor (VEGFR) tyrosine kinase inhibitor therapy, Met tyrosine kinase&#xD;
             inhibitor therapy, or Met monoclonal antibody (MetMAb); prior antibody therapy such as&#xD;
             bevacizumab or cetuximab is allowed with a washout period depending on dosing interval&#xD;
             and investigational nature&#xD;
&#xD;
          -  Prior radiation therapy to the thoracic cavity, abdomen, or pelvis within 3 months&#xD;
             prior to registration, to bone or brain metastasis within 14 days prior to&#xD;
             registration, or to any other site within 28 days prior to registration&#xD;
&#xD;
          -  History of the following: Clinically-significant gastrointestinal (GI) bleeding within&#xD;
             6 months prior to registration; Hemoptysis of &gt;= 0.5 teaspoon (2.5 mL) of red blood&#xD;
             within 3 months prior to registration; Any other signs indicative of pulmonary&#xD;
             hemorrhage within 3 months prior to registration&#xD;
&#xD;
          -  Radiographic or other evidence of the following within 28 days prior to registration:&#xD;
             • Tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or&#xD;
             anus), or any evidence of endotracheal or endobronchial tumor; Cavitating pulmonary&#xD;
             lesion(s); Tumor in contact with, invading or encasing any major blood vessels&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  History of major thrombotic events (deep vein thrombosis [DVT] or pulmonary embolism&#xD;
             [PE]) within 6 months prior to registration&#xD;
&#xD;
          -  Concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or&#xD;
             warfarin-related agents, heparin, low molecular weight heparin (LMWH), thrombin or&#xD;
             Factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel). (low dose aspirin&#xD;
             [=&lt; 81 mg/day] and prophylactic LMWH are permitted)&#xD;
&#xD;
          -  Concomitant treatment of strong cytochrome P450 3A4 (CYP3A4) inducers (e.g.,&#xD;
             dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine,&#xD;
             phenobarbital, and St. John's wort)&#xD;
&#xD;
          -  Cardiovascular disorders including: Congestive heart failure (CHF): New York Heart&#xD;
             Association (NYHA) class III (moderate) or class IV (severe) at the time of screening;&#xD;
&#xD;
          -  Concurrent uncontrolled hypertension; Any history of congenital long QT syndrome; Any&#xD;
             of the following within 6 months prior to registration:&#xD;
&#xD;
               -  Unstable angina pectoris&#xD;
&#xD;
               -  Clinically-significant cardiac arrhythmias&#xD;
&#xD;
               -  Stroke (including transient ischemic attack [TIA], or other ischemic event)&#xD;
&#xD;
               -  Myocardial infarction&#xD;
&#xD;
          -  GI disorders particularly those associated with a high risk of perforation or fistula&#xD;
             formation specified in the protocol&#xD;
&#xD;
          -  Other disorders associated with a high risk of fistula formation including&#xD;
             percutaneous endoscopic gastrostomy (PEG) tube placement within 3 months prior to&#xD;
             registration&#xD;
&#xD;
          -  Uncontrolled, significant, intercurrent or recent illness&#xD;
&#xD;
          -  Prior malignancy within 2 years prior to registration which required systemic&#xD;
             treatment or is currently active&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Patients with known human immunodeficiency virus (HIV) disease taking antiretroviral&#xD;
             therapy&#xD;
&#xD;
          -  Known chronic active hepatitis B&#xD;
&#xD;
          -  EXCLUSION CRITERIA (STEP 2):&#xD;
&#xD;
          -  Intervening anticancer treatment or major surgical procedure(s) between Step 1 and&#xD;
             Step 2, except palliative radiation to the bone finishing &gt;= 2 weeks prior to&#xD;
             registration to Step 2&#xD;
&#xD;
          -  Central nervous system (CNS) progression; patients with stable CNS disease are allowed&#xD;
&#xD;
          -  Intercurrent illness or disease complication that the investigator believes would&#xD;
             limit the ability to safely tolerate the combination of erlotinib and cabozantinib&#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>Joel W Neal</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Monterey Peninsula</name>
      <address>
        <city>Monterey</city>
        <state>California</state>
        <zip>93940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Palo Alto Health Care System</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisenhower Medical Center</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Center of Aurora</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boulder Community Hospital</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Boulder</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Penrose</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porter Adventist Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Blood Cancer Institute</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian - Saint Lukes Medical Center - Health One</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Midtown</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCL Health Saint Joseph Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Rose</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rose Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western States Cancer Research NCORP</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Blue Cancer Care Center - Swedish</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Blue Cancer Care Center</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Colorado Medical Center</name>
      <address>
        <city>Greeley</city>
        <state>Colorado</state>
        <zip>80631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Greenwood Village</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Lakewood</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Anthony Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Littleton Adventist Hospital</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Sky Ridge</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sky Ridge Medical Center</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longmont United Hospital</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Longmont</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKee Medical Center</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parker Adventist Hospital</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Parker</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary Corwin Medical Center</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers - Pueblo</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCL Health Lutheran Medical Center</name>
      <address>
        <city>Wheat Ridge</city>
        <state>Colorado</state>
        <zip>80033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital Care Center at Saint Francis</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital of Central Connecticut</name>
      <address>
        <city>New Britain</city>
        <state>Connecticut</state>
        <zip>06050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beebe Medical Center</name>
      <address>
        <city>Lewes</city>
        <state>Delaware</state>
        <zip>19958</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Gynecologic Oncology LLC</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Clinical and Laboratory Physicians PA</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen F Graham Cancer Center</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Hematology Consultants PA</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health System-Christiana Hospital</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beebe Health Campus</name>
      <address>
        <city>Rehoboth Beach</city>
        <state>Delaware</state>
        <zip>19971</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TidalHealth Nanticoke / Allen Cancer Center</name>
      <address>
        <city>Seaford</city>
        <state>Delaware</state>
        <zip>19973</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care Health System-Wilmington Hospital</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital/Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Saint Joseph's Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of Central Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis Cancer and Research Pavilion at Saint Joseph's/Candler</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush - Copley Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Medical Center</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Canton</name>
      <address>
        <city>Canton</city>
        <state>Illinois</state>
        <zip>61520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Carthage</name>
      <address>
        <city>Carthage</city>
        <state>Illinois</state>
        <zip>62321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralia Oncology Clinic</name>
      <address>
        <city>Centralia</city>
        <state>Illinois</state>
        <zip>62801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle at The Riverfront</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Cancer Research NCORP</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Eureka</name>
      <address>
        <city>Eureka</city>
        <state>Illinois</state>
        <zip>61530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Evanston Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Galesburg</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Glenbrook Hospital</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hospital</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Illinois-Highland Park</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem-Highland Park Hospital</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presence Saint Mary's Hospital</name>
      <address>
        <city>Kankakee</city>
        <state>Illinois</state>
        <zip>60901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Kewanee Clinic</name>
      <address>
        <city>Kewanee</city>
        <state>Illinois</state>
        <zip>61443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMG Libertyville - Oncology</name>
      <address>
        <city>Libertyville</city>
        <state>Illinois</state>
        <zip>60048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Macomb</name>
      <address>
        <city>Macomb</city>
        <state>Illinois</state>
        <zip>61455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Garneau, Stewart C MD (UIA Investigator)</name>
      <address>
        <city>Moline</city>
        <state>Illinois</state>
        <zip>61265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porubcin, Michael MD (UIA Investigator)</name>
      <address>
        <city>Moline</city>
        <state>Illinois</state>
        <zip>61265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spector, David MD (UIA Investigator)</name>
      <address>
        <city>Moline</city>
        <state>Illinois</state>
        <zip>61265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Medical Center</name>
      <address>
        <city>Moline</city>
        <state>Illinois</state>
        <zip>61265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Monmouth</name>
      <address>
        <city>Monmouth</city>
        <state>Illinois</state>
        <zip>61462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists-Niles</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Institute Normal</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Ottawa Clinic</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Regional Hospital and Healthcare Center</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Pekin</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Proctor Hospital</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Medical Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peru</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Valley Hospital</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Princeton</name>
      <address>
        <city>Princeton</city>
        <state>Illinois</state>
        <zip>61356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish American Hospital</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SwedishAmerican Regional Cancer Center/ACT</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Illinois - Skokie</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush-Copley Healthcare Center</name>
      <address>
        <city>Yorkville</city>
        <state>Illinois</state>
        <zip>60560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elkhart Clinic</name>
      <address>
        <city>Elkhart</city>
        <state>Indiana</state>
        <zip>46514-2098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michiana Hematology Oncology PC-Elkhart</name>
      <address>
        <city>Elkhart</city>
        <state>Indiana</state>
        <zip>46514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elkhart General Hospital</name>
      <address>
        <city>Elkhart</city>
        <state>Indiana</state>
        <zip>46515</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University/Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Central Indiana Cancer Centers-East</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Howard Regional Health</name>
      <address>
        <city>Kokomo</city>
        <state>Indiana</state>
        <zip>46904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health La Porte Hospital</name>
      <address>
        <city>La Porte</city>
        <state>Indiana</state>
        <zip>46350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Saint Anthony Health-Michigan City</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodland Cancer Care Center</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michiana Hematology Oncology PC-Mishawaka</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Regional Medical Center-Mishawaka</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Ball Memorial Hospital</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michiana Hematology Oncology PC-Plymouth</name>
      <address>
        <city>Plymouth</city>
        <state>Indiana</state>
        <zip>46563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of South Bend</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michiana Hematology Oncology PC-South Bend</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Bend Clinic</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Indiana Cancer Research Consortium</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michiana Hematology Oncology PC-Westville</name>
      <address>
        <city>Westville</city>
        <state>Indiana</state>
        <zip>46391</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Greeley Medical Center</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Ames</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Constantinou, Costas L MD (UIA Investigator)</name>
      <address>
        <city>Bettendorf</city>
        <state>Iowa</state>
        <zip>52722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Boone</name>
      <address>
        <city>Boone</city>
        <state>Iowa</state>
        <zip>50036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Associates at Mercy Medical Center</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-West Des Moines</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center-West Lakes</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa-Wide Oncology Research Coalition NCORP</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Cancer and Blood - Laurel</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Lutheran Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Jefferson</name>
      <address>
        <city>Jefferson</city>
        <state>Iowa</state>
        <zip>50129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Marshalltown</name>
      <address>
        <city>Marshalltown</city>
        <state>Iowa</state>
        <zip>50158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - North Iowa</name>
      <address>
        <city>Mason City</city>
        <state>Iowa</state>
        <zip>50401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siouxland Regional Cancer Center</name>
      <address>
        <city>Sioux City</city>
        <state>Iowa</state>
        <zip>51101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center-Sioux City</name>
      <address>
        <city>Sioux City</city>
        <state>Iowa</state>
        <zip>51102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Regional Medical Center</name>
      <address>
        <city>Sioux City</city>
        <state>Iowa</state>
        <zip>51104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center-West Lakes</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Chanute</name>
      <address>
        <city>Chanute</city>
        <state>Kansas</state>
        <zip>66720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Dodge City</name>
      <address>
        <city>Dodge City</city>
        <state>Kansas</state>
        <zip>67801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - El Dorado</name>
      <address>
        <city>El Dorado</city>
        <state>Kansas</state>
        <zip>67042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Fort Scott</name>
      <address>
        <city>Fort Scott</city>
        <state>Kansas</state>
        <zip>66701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Independence</name>
      <address>
        <city>Independence</city>
        <state>Kansas</state>
        <zip>67301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Kingman</name>
      <address>
        <city>Kingman</city>
        <state>Kansas</state>
        <zip>67068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Memorial Hospital</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Liberal</name>
      <address>
        <city>Liberal</city>
        <state>Kansas</state>
        <zip>67905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Manhattan</name>
      <address>
        <city>Manhattan</city>
        <state>Kansas</state>
        <zip>66502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - McPherson</name>
      <address>
        <city>McPherson</city>
        <state>Kansas</state>
        <zip>67460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Newton</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Parsons</name>
      <address>
        <city>Parsons</city>
        <state>Kansas</state>
        <zip>67357</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Pratt</name>
      <address>
        <city>Pratt</city>
        <state>Kansas</state>
        <zip>67124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Salina</name>
      <address>
        <city>Salina</city>
        <state>Kansas</state>
        <zip>67401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Wellington</name>
      <address>
        <city>Wellington</city>
        <state>Kansas</state>
        <zip>67152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associates In Womens Health</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Wichita Medical Arts Tower</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi Hospitals Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wichita NCI Community Oncology Research Program</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Winfield</name>
      <address>
        <city>Winfield</city>
        <state>Kansas</state>
        <zip>67156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Health Center-Summa</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Baptist Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <state>Maine</state>
        <zip>03909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christiana Care - Union Hospital</name>
      <address>
        <city>Elkton</city>
        <state>Maryland</state>
        <zip>21921</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bixby Medical Center</name>
      <address>
        <city>Adrian</city>
        <state>Michigan</state>
        <zip>49221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hickman Cancer Center</name>
      <address>
        <city>Adrian</city>
        <state>Michigan</state>
        <zip>49221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Cancer Research Consortium NCORP</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital - Dearborn</name>
      <address>
        <city>Dearborn</city>
        <state>Michigan</state>
        <zip>48124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology - Escanaba</name>
      <address>
        <city>Escanaba</city>
        <state>Michigan</state>
        <zip>49829</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Hurley Cancer Institute</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology - Iron Mountain</name>
      <address>
        <city>Iron Mountain</city>
        <state>Michigan</state>
        <zip>49801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegiance Health</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Michigan Cancer Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borgess Medical Center</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health Saint Mary Mercy Livonia Hospital</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Memorial Hospital</name>
      <address>
        <city>Monroe</city>
        <state>Michigan</state>
        <zip>48162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers-Monroe</name>
      <address>
        <city>Monroe</city>
        <state>Michigan</state>
        <zip>48162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Oakland</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lake Huron Medical Center</name>
      <address>
        <city>Port Huron</city>
        <state>Michigan</state>
        <zip>48060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Mary's Hospital</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeland Medical Center Saint Joseph</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marie Yeager Cancer Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Michigan</state>
        <zip>49085</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Macomb-Oakland Hospital</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Joe Lueken Cancer Center</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Ridges Hospital</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairview Southdale Hospital</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hutchinson Area Health Care</name>
      <address>
        <city>Hutchinson</city>
        <state>Minnesota</state>
        <zip>55350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Maplewood</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John's Hospital - Healtheast</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott-Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Ulm Medical Center</name>
      <address>
        <city>New Ulm</city>
        <state>Minnesota</state>
        <zip>56073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Memorial Medical Health Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Minnesota Community Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic - Saint Louis Park</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Regional Medical Center</name>
      <address>
        <city>Shakopee</city>
        <state>Minnesota</state>
        <zip>55379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeview Hospital</name>
      <address>
        <city>Stillwater</city>
        <state>Minnesota</state>
        <zip>55082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ridgeview Medical Center</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rice Memorial Hospital</name>
      <address>
        <city>Willmar</city>
        <state>Minnesota</state>
        <zip>56201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Woodbury</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Research Center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Valley Cancer Consortium</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Immanuel Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Bergan Mercy Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Lakeside Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton University Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Cancer Center-Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Southeast Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Shadow</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Central</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-San Martin</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Southeast</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Therapy and Integrative Medicine</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer and Blood Specialists-Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Northwest</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Vegas Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Tenaya</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Summerlin</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Las Vegas Cancer Center-Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148-2405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Fort Apache</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Fort Apache</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89149</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Central Valley</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Cancer Research Foundation NCORP</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper Hospital University Medical Center</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Adminstration New Jersey Health Care System</name>
      <address>
        <city>East Orange</city>
        <state>New Jersey</state>
        <zip>07018-1095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monmouth Medical Center</name>
      <address>
        <city>Long Branch</city>
        <state>New Jersey</state>
        <zip>07740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virtua Memorial</name>
      <address>
        <city>Mount Holly</city>
        <state>New Jersey</state>
        <zip>08060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers New Jersey Medical School</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlook Hospital</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inspira Medical Center Vineland</name>
      <address>
        <city>Vineland</city>
        <state>New Jersey</state>
        <zip>08360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center - Las Cruces</name>
      <address>
        <city>Las Cruces</city>
        <state>New Mexico</state>
        <zip>88011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center-Weiler Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dickstein Cancer Treatment Center</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Broadway Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Clinic North-Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summa Health System - Akron Campus</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strecker Cancer Center-Belpre</name>
      <address>
        <city>Belpre</city>
        <state>Ohio</state>
        <zip>45714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers-Bowling Green</name>
      <address>
        <city>Bowling Green</city>
        <state>Ohio</state>
        <zip>43402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Mercy Hospital</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adena Regional Medical Center</name>
      <address>
        <city>Chillicothe</city>
        <state>Ohio</state>
        <zip>45601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Oncology and Hematology Associates Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus NCI Community Oncology Research Program</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grant Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mark H Zangmeister Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Carmel Health Center West</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctors Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Health Center-Grady Cancer Center</name>
      <address>
        <city>Delaware</city>
        <state>Ohio</state>
        <zip>43015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Radiation Oncology</name>
      <address>
        <city>Delaware</city>
        <state>Ohio</state>
        <zip>43015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Delaware</city>
        <state>Ohio</state>
        <zip>43015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fairfield Medical Center</name>
      <address>
        <city>Lancaster</city>
        <state>Ohio</state>
        <zip>43130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Rita's Medical Center</name>
      <address>
        <city>Lima</city>
        <state>Ohio</state>
        <zip>45801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lima Memorial Hospital</name>
      <address>
        <city>Lima</city>
        <state>Ohio</state>
        <zip>45804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marietta Memorial Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Ohio</state>
        <zip>45750</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers-Maumee</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <zip>43537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knox Community Hospital</name>
      <address>
        <city>Mount Vernon</city>
        <state>Ohio</state>
        <zip>43050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Licking Memorial Hospital</name>
      <address>
        <city>Newark</city>
        <state>Ohio</state>
        <zip>43055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Radiation Oncology</name>
      <address>
        <city>Newark</city>
        <state>Ohio</state>
        <zip>43055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Charles Hospital</name>
      <address>
        <city>Oregon</city>
        <state>Ohio</state>
        <zip>43616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers-Oregon</name>
      <address>
        <city>Oregon</city>
        <state>Ohio</state>
        <zip>43616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Ohio Medical Center</name>
      <address>
        <city>Portsmouth</city>
        <state>Ohio</state>
        <zip>45662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Regional Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMedica Flower Hospital</name>
      <address>
        <city>Sylvania</city>
        <state>Ohio</state>
        <zip>43560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital of Tiffin</name>
      <address>
        <city>Tiffin</city>
        <state>Ohio</state>
        <zip>44883</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Mercy Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Community Hospital Oncology Program CCOP</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health - Saint Anne Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers-Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fulton County Health Center</name>
      <address>
        <city>Wauseon</city>
        <state>Ohio</state>
        <zip>43567</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Ann's Hospital</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Healthcare System Cancer Care Center</name>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryn Mawr Hospital</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doylestown Hospital</name>
      <address>
        <city>Doylestown</city>
        <state>Pennsylvania</state>
        <zip>18901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center Erie</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center-Cancer Center Hazleton</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster General Hospital</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Oncology-Lewisburg</name>
      <address>
        <city>Lewisburg</city>
        <state>Pennsylvania</state>
        <zip>17837</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paoli Memorial Hospital</name>
      <address>
        <city>Paoli</city>
        <state>Pennsylvania</state>
        <zip>19301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Einstein Medical Center Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Cancer Services-Pottsville</name>
      <address>
        <city>Pottsville</city>
        <state>Pennsylvania</state>
        <zip>17901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guthrie Medical Group PC-Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Group</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Wyoming Valley/Henry Cancer Center</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Main Line Health NCORP</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health-York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dell Seton Medical Center at The University of Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Therapy and Research Center at The UT Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Tyler</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fredericksburg Oncology Inc</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Charleston Division</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Healthcare</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheeling Hospital/Schiffler Cancer Center</name>
      <address>
        <city>Wheeling</city>
        <state>West Virginia</state>
        <zip>26003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Chippewa Center</name>
      <address>
        <city>Chippewa Falls</city>
        <state>Wisconsin</state>
        <zip>54729</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS Sacred Heart Hospital</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic Cancer Center at Sacred Heart</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology at Saint Vincent Hospital</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301-3526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology Limited at Saint Mary's Hospital</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Saint Mary's</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Cancer Center Johnson Creek</name>
      <address>
        <city>Johnson Creek</city>
        <state>Wisconsin</state>
        <zip>53038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean Hematology and Oncology Clinic</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Family Memorial Hospital</name>
      <address>
        <city>Manitowoc</city>
        <state>Wisconsin</state>
        <zip>54221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Medical Center</name>
      <address>
        <city>Marinette</city>
        <state>Wisconsin</state>
        <zip>54143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Minocqua Center</name>
      <address>
        <city>Minocqua</city>
        <state>Wisconsin</state>
        <zip>54548</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Western Wisconsin</name>
      <address>
        <city>New Richmond</city>
        <state>Wisconsin</state>
        <zip>54017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProHealth Oconomowoc Memorial Hospital</name>
      <address>
        <city>Oconomowoc</city>
        <state>Wisconsin</state>
        <zip>53066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Oconto Falls</name>
      <address>
        <city>Oconto Falls</city>
        <state>Wisconsin</state>
        <zip>54154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Mary's Hospital</name>
      <address>
        <city>Rhinelander</city>
        <state>Wisconsin</state>
        <zip>54501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital</name>
      <address>
        <city>Rhinelander</city>
        <state>Wisconsin</state>
        <zip>54501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Rice Lake</name>
      <address>
        <city>Rice Lake</city>
        <state>Wisconsin</state>
        <zip>54868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS Saint Nicholas Hospital</name>
      <address>
        <city>Sheboygan</city>
        <state>Wisconsin</state>
        <zip>53081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Michael's Hospital</name>
      <address>
        <city>Stevens Point</city>
        <state>Wisconsin</state>
        <zip>54481</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology - Sturgeon Bay</name>
      <address>
        <city>Sturgeon Bay</city>
        <state>Wisconsin</state>
        <zip>54235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ProHealth Waukesha Memorial Hospital</name>
      <address>
        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Wausau Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Clare's Hospital</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic and Treatment Center</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Weston</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Cancer Care - Wisconsin Rapids</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic - Wisconsin Rapids Center</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <results_first_submitted>October 6, 2016</results_first_submitted>
  <results_first_submitted_qc>October 6, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2016</results_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erlotinib Hydrochloride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was activated on February 7, 2013 and closed to accrual on July 1, 2014 with final accrual of 125 patients. Among these, a total of 20 patients registered to Step 2.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A (Erlotinib)</title>
          <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P2">
          <title>Arm B (Cabozantinib)</title>
          <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P3">
          <title>Arm C (Erlotinib+Cabozantinib)</title>
          <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Step 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started Protocol Therapy</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Eligible and Treated</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patients With MET Status Data Available</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Treatment continued until progressive disease or unacceptable toxicity.</participants>
                <participants group_id="P2" count="0">Treatment continued until progressive disease or unacceptable toxicity.</participants>
                <participants group_id="P3" count="0">Treatment continued until progressive disease or unacceptable toxicity.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="43"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other complicating disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Crossed over to Step 2</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Symptomatic deterioration</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Off-treatment reason not submitted</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ineligible or never received treatment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Step 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13">Only patients with disease progression in Step 1 are eligible to register to Step 2.</participants>
                <participants group_id="P2" count="7">Only patients with disease progression in Step 1 are eligible to register to Step 2.</participants>
                <participants group_id="P3" count="0">Only patients with disease progression on Arms A and B were allowed to register to Step 2.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Treatment continued until progressive disease or unacceptable toxicity.</participants>
                <participants group_id="P2" count="0">Treatment continued until progressive disease or unacceptable toxicity.</participants>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </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 group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Eligible and treated patients</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A (Erlotinib)</title>
          <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B2">
          <title>Arm B (Cabozantinib)</title>
          <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B3">
          <title>Arm C (Erlotinib+Cabozantinib)</title>
          <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B4">
          <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="38"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="35"/>
            <count group_id="B4" value="111"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" lower_limit="34" upper_limit="83"/>
                    <measurement group_id="B2" value="65" lower_limit="46" upper_limit="88"/>
                    <measurement group_id="B3" value="63" lower_limit="44" upper_limit="82"/>
                    <measurement group_id="B4" value="66" lower_limit="34" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS)</title>
        <description>PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.</description>
        <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
        <population>Eligible and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Erlotinib)</title>
            <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Cabozantinib)</title>
            <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Arm C (Erlotinib+Cabozantinib)</title>
            <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS)</title>
          <description>PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.</description>
          <population>Eligible and treated patients</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="38"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.7" upper_limit="2.2"/>
                    <measurement group_id="O2" value="4.3" lower_limit="3.6" upper_limit="7.4"/>
                    <measurement group_id="O3" value="4.7" lower_limit="2.4" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.37</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.25</ci_lower_limit>
            <ci_upper_limit>0.53</ci_upper_limit>
            <estimate_desc>Hazard ratio of Arm C/Arm A</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.39</param_value>
            <ci_percent>80</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.27</ci_lower_limit>
            <ci_upper_limit>0.55</ci_upper_limit>
            <estimate_desc>Hazard ratio of Arm B/Arm A</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from randomization to death from any cause or date of last known alive.</description>
        <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
        <population>Eligible and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Erlotinib)</title>
            <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Cabozantinib)</title>
            <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Arm C (Erlotinib+Cabozantinib)</title>
            <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time from randomization to death from any cause or date of last known alive.</description>
          <population>Eligible and treated patients</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="38"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="3.3" upper_limit="9.3"/>
                    <measurement group_id="O2" value="9.2" lower_limit="5.1" upper_limit="15.0"/>
                    <measurement group_id="O3" value="13.3" lower_limit="7.6" upper_limit="NA">The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Objective Response</title>
        <description>Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).</description>
        <time_frame>Assessed every 3 months if patient is &lt; 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years</time_frame>
        <population>Eligible and treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Erlotinib)</title>
            <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Cabozantinib)</title>
            <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Arm C (Erlotinib+Cabozantinib)</title>
            <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Objective Response</title>
          <description>Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).</description>
          <population>Eligible and treated patients</population>
          <units>proportion 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="38"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" lower_limit="0.0009" upper_limit="0.141"/>
                    <measurement group_id="O2" value="0.11" lower_limit="0.03" upper_limit="0.25"/>
                    <measurement group_id="O3" value="0.03" lower_limit="0.001" upper_limit="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With MET Positivity</title>
        <description>Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.</description>
        <time_frame>Assessed at baseline</time_frame>
        <population>Eligible and treated patients who had sufficient samples for MET expression analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Erlotinib)</title>
            <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Cabozantinib)</title>
            <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Arm C (Erlotinib+Cabozantinib)</title>
            <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With MET Positivity</title>
          <description>Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.</description>
          <population>Eligible and treated patients who had sufficient samples for MET expression analysis.</population>
          <units>proportion 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="30"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" lower_limit="0.61" upper_limit="0.92"/>
                    <measurement group_id="O2" value="0.81" lower_limit="0.64" upper_limit="0.93"/>
                    <measurement group_id="O3" value="0.96" lower_limit="0.79" upper_limit="0.999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher</title>
        <time_frame>Assessed every 4 weeks while on treatment and for 30 days after the end of treatment</time_frame>
        <population>All patients who received protocol therapy</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Erlotinib)</title>
            <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Cabozantinib)</title>
            <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Arm C (Erlotinib+Cabozantinib)</title>
            <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher</title>
          <population>All patients who received protocol therapy</population>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.325" lower_limit="0.204" upper_limit="0.466"/>
                    <measurement group_id="O2" value="0.70" lower_limit="0.560" upper_limit="0.817"/>
                    <measurement group_id="O3" value="0.718" lower_limit="0.577" upper_limit="0.833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Assessed every 4 weeks while on treatment and for 30 days after the end of treatment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm A (Erlotinib)</title>
          <description>Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Arm B (Cabozantinib)</title>
          <description>Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E3">
          <title>Arm C (Erlotinib+Cabozantinib)</title>
          <description>Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E4">
          <title>Arm Z (Erlotinib+Cabozantinib; Step 2)</title>
          <description>Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Muscle weakness lower limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cognitive disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Intracranial hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE 4.0</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="35" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="38" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Endocrine disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Watering eyes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Proctitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Voice alteration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nail loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, specify</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Statistician</name_or_title>
      <organization>ECOG-ACRIN Statistical Office</organization>
      <phone>617-632-3012</phone>
    </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/NCT01708954
org study id: NCI-2012-01938
secondary id: NCI-2012-01938
secondary id: ECOG-E1512
secondary id: CDR0000741879
secondary id: E1512
secondary id: E1512
secondary id: U10CA180820
secondary id: U10CA021115
nct id: NCT01708954
lead sponsor: 
has dmc: Yes
This randomized phase II trial studies how well giving erlotinib hydrochloride and
      cabozantinib-s-malate alone or in combination works as second or third line therapy in
      treating patient with stage IV non-small cell lung cancer. Erlotinib hydrochloride and
      cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. It is not yet known whether giving erlotinib hydrochloride together
      with cabozantinib-s-malate is more effective than erlotinib hydrochloride or
      cabozantinib-s-malate alone in treating non-small cell lung cancer.
PRIMARY OBJECTIVES:

      I. To compare the progression-free survival (PFS) associated with patients treated with
      erlotinib (erlotinib hydrochloride) versus (vs) erlotinib plus cabozantinib
      (cabozantinib-s-malate).

      II. To compare the PFS associated with patients treated with erlotinib vs cabozantinib.

      SECONDARY OBJECTIVES:

      I. To evaluate overall survival in the three treatment arms. II. To evaluate best objective
      response rate in the three treatment arms. III. To define the toxicity associated with each
      regimen. IV. To conduct correlative science studies that will help to select predictive
      biomarkers of response to therapy, including mesenchymal-epidermal transition (MET)
      expression and potentially other tissue biomarkers, plasma biomarkers, and bone scans.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

      ARM A (erlotinib): Patients receive erlotinib orally (PO) daily on days 1-28. Courses repeat
      every 28 days in the absence of disease progression or unacceptable toxicity.

      ARM B (cabozantinib): Patients receive cabozantinib PO daily on days 1-28. Courses repeat
      every 28 days in the absence of disease progression or unacceptable toxicity.

      ARM C (erlotinib+cabozantinib): Patients receive erlotinib as patients in Arm A and
      cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease
      progression or unacceptable toxicity.

      ARM Z: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and
      cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for 2 years and
      then every 6 months for 3 years.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free Survival (PFS)
time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
description: PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.
measure: Overall Survival (OS)
time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
description: OS is defined as the time from randomization to death from any cause or date of last known alive.
measure: Proportion of Patients With Objective Response
time frame: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years
description: Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).
measure: Proportion of Patients With MET Positivity
time frame: Assessed at baseline
description: Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.
measure: Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher
time frame: Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
arm group label: Arm A (erlotinib)
arm group type: Experimental
description: Patients receive erlotinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arm group label: Arm B (cabozantinib)
arm group type: Experimental
description: Patients receive cabozantinib PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arm group label: Arm C (erlotinib+cabozantinib)
arm group type: Experimental
description: Patients receive erlotinib as patients in Arm A and cabozantinib as patients in Arm B. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
arm group label: Arm Z (erlotinib+cabozantinib; step II)
arm group type: Experimental
description: Patients achieving disease progression in Arm A or Arm B may receive erlotinib and cabozantinib as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Cabozantinib S-malate
description: Given PO
arm group label: Arm B (cabozantinib)
arm group label: Arm C (erlotinib+cabozantinib)
arm group label: Arm Z (erlotinib+cabozantinib; step II)
other name: BMS-907351
other name: Cabometyx
other name: Cometriq
other name: XL-184
other name: XL184
intervention type: Drug
intervention name: Erlotinib Hydrochloride
description: Given PO
arm group label: Arm A (erlotinib)
arm group label: Arm C (erlotinib+cabozantinib)
arm group label: Arm Z (erlotinib+cabozantinib; step II)
other name: Cp-358,774
other name: OSI-774
other name: Tarceva
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm A (erlotinib)
arm group label: Arm B (cabozantinib)
arm group label: Arm C (erlotinib+cabozantinib)
arm group label: Arm Z (erlotinib+cabozantinib; step II)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel W Neal
role: Principal Investigator
affiliation: ECOG-ACRIN Cancer Research Group
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Erlotinib Hydrochloride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 