<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/NCT01716715</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2012-02058</org_study_id>
    <secondary_id>NCI-2012-02058</secondary_id>
    <secondary_id>GOG-0186K</secondary_id>
    <secondary_id>S13-00312</secondary_id>
    <secondary_id>GOG-0186K</secondary_id>
    <secondary_id>GOG-0186K</secondary_id>
    <secondary_id>U10CA180868</secondary_id>
    <secondary_id>U10CA027469</secondary_id>
    <nct_id>NCT01716715</nct_id>
  </id_info>
  <brief_title>Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer</brief_title>
  <official_title>A Randomized Phase II Study of NCI Supplied Cabozantinib (NSC #761968) Versus Weekly Paclitaxel (NSC #673089) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer</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 cabozantinib-s-malate or paclitaxel&#xD;
      works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube,&#xD;
      or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells&#xD;
      by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as&#xD;
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the&#xD;
      cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or&#xD;
      paclitaxel is more effective at treating patients with persistent or recurrent epithelial&#xD;
      ovarian, fallopian tube, or primary peritoneal cavity cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the activity of cabozantinib (cabozantinib-s-malate) relative to weekly&#xD;
      paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary&#xD;
      peritoneal cancer with a log-rank test assessing progression-free survival (PFS) at 3.68&#xD;
      months (approximately pre-cycle 5) and 7.36 months (approximately pre-cycle 9).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the frequency and severity of adverse events as assessed by Common&#xD;
      Terminology Criteria for Adverse Events (CTCAE).&#xD;
&#xD;
      II. To estimate and compare the proportion of patients responding to therapy by Response&#xD;
      Evaluation Criteria for Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the&#xD;
      overall survival (OS), and the duration of response in each arm.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To retrospectively correlate c-met proto-oncogene (MET) expression with overall outcome.&#xD;
&#xD;
      II. To retrospectively correlate c-MET copy number with overall outcome.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28.&#xD;
&#xD;
      ARM II: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15.&#xD;
&#xD;
      In both arms, courses repeat every 28 days in the absence of disease progression or&#xD;
      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>Completed</overall_status>
  <start_date type="Actual">November 6, 2012</start_date>
  <completion_date type="Actual">February 9, 2019</completion_date>
  <primary_completion_date type="Actual">March 16, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event Free Survival</measure>
    <time_frame>The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks</time_frame>
    <description>Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or Higher Adverse Events by Type</measure>
    <time_frame>Up to 30 days after completion of study treatment</time_frame>
    <description>Toxicities will be characterized by their frequency and severity, grade 3 and above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response, Assessed According to RECIST Version 1.1</measure>
    <time_frame>CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years</time_frame>
    <description>Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With CA125 Response.</measure>
    <time_frame>Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.</time_frame>
    <description>Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.</time_frame>
    <description>The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Estimate the Response Duration Among Patients Who Respond.</measure>
    <time_frame>From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.</time_frame>
    <description>The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
  </secondary_outcome>
  <other_outcome>
    <measure>c-Met Expression</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>c-MET Copy Number</measure>
    <time_frame>Baseline</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Recurrent Fallopian Tube Carcinoma</condition>
  <condition>Recurrent Ovarian Carcinoma</condition>
  <condition>Recurrent Primary Peritoneal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (cabozantinib-s-malate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive cabozantinib-s-malate PO QD on days 1-28.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (paclitaxel)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cabozantinib S-malate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm I (cabozantinib-s-malate)</arm_group_label>
    <other_name>BMS-907351</other_name>
    <other_name>Cabometyx</other_name>
    <other_name>Cometriq</other_name>
    <other_name>XL184</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (cabozantinib-s-malate)</arm_group_label>
    <arm_group_label>Arm II (paclitaxel)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm II (paclitaxel)</arm_group_label>
    <other_name>Anzatax</other_name>
    <other_name>Asotax</other_name>
    <other_name>Bristaxol</other_name>
    <other_name>Praxel</other_name>
    <other_name>Taxol</other_name>
    <other_name>Taxol Konzentrat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube or&#xD;
             primary peritoneal carcinoma; histologic documentation of the original primary tumor&#xD;
             is required via the pathology report&#xD;
&#xD;
          -  Patients must have measurable disease or non-measurable (detectable) disease:&#xD;
&#xD;
               -  Measurable disease is defined as at least one lesion that can be accurately&#xD;
                  measured in at least one dimension (longest diameter to be recorded); each lesion&#xD;
                  must be greater than or equal to 10 mm when measured by computed tomography (CT),&#xD;
                  magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or&#xD;
                  greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be&#xD;
                  greater than or equal to 15 mm in short axis when measured by CT or MRI&#xD;
&#xD;
               -  Non-measurable (detectable) disease is defined in this protocol as the absence of&#xD;
                  measurable disease but at least one of the following conditions:&#xD;
&#xD;
                    -  Ascites and/or pleural effusion attributed to tumor&#xD;
&#xD;
                    -  Solid and/or cystic abnormalities on radiographic imaging that do not meet&#xD;
                       RECIST 1.1 definitions for target lesions&#xD;
&#xD;
          -  Patients with measurable disease must have at least one &quot;target lesion&quot; to be used to&#xD;
             assess response on this protocol as defined by RECIST 1.1; tumors within a previously&#xD;
             irradiated field will be designated as &quot;non-target&quot; lesions unless progression is&#xD;
             documented or a biopsy is obtained to confirm persistence at least 90 days following&#xD;
             completion of radiation therapy&#xD;
&#xD;
          -  Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG)&#xD;
             protocol, if one exists; in general, this would refer to any active GOG phase III or&#xD;
             rare tumor protocol for the same patient population; in addition, patients must not be&#xD;
             eligible for the currently active phase II cytotoxic protocol in platinum resistant&#xD;
             disease&#xD;
&#xD;
          -  Patients must have a GOG performance status of 0, 1, or 2&#xD;
&#xD;
          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy to baseline or&#xD;
             CTCAE =&lt; grade 1 toxicity from all prior therapies except alopecia and other&#xD;
             non-clinically significant adverse events (AE's):&#xD;
&#xD;
               -  Patients should be free of active infection requiring antibiotics (with the&#xD;
                  exception of uncomplicated urinary tract infection [UTI])&#xD;
&#xD;
               -  Any hormonal therapy directed at the malignant tumor must be discontinued at&#xD;
                  least one week prior to treatment&#xD;
&#xD;
               -  Any other prior therapy directed at the malignant tumor, including chemotherapy,&#xD;
                  biological/targeted (non-cytotoxic) agents and immunologic agents, must be&#xD;
                  discontinued at least three weeks prior to treatment&#xD;
&#xD;
               -  Chimeric or human or humanized monoclonal antibodies (including bevacizumab) or&#xD;
                  vascular endothelial growth factor (VEGF) receptor fusion proteins (including&#xD;
                  VEGF TRAP/aflibercept) must be discontinued for at least 12 weeks prior to&#xD;
                  treatment&#xD;
&#xD;
               -  Investigational agents must be discontinued for at least 28 days prior to&#xD;
                  treatment&#xD;
&#xD;
               -  Any prior radiation therapy must be discontinued at least four weeks prior to&#xD;
                  treatment&#xD;
&#xD;
          -  Prior therapy&#xD;
&#xD;
               -  Patients must have had one prior platinum-based chemotherapeutic regimen for&#xD;
                  management of primary disease containing carboplatin, cisplatin, or another&#xD;
                  organoplatinum compound; this initial treatment may have included intraperitoneal&#xD;
                  therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g.,&#xD;
                  bevacizumab) or extended therapy administered after surgical or non-surgical&#xD;
                  assessment; if patients were treated with paclitaxel for their primary disease,&#xD;
                  this could have been given weekly or every 3 weeks&#xD;
&#xD;
               -  Patients are allowed to receive, but are not required to receive, two additional&#xD;
                  cytotoxic regimens for management of recurrent or persistent disease, with no&#xD;
                  more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel&#xD;
                  for recurrent or persistent disease is NOT allowed&#xD;
&#xD;
               -  Patients are allowed to receive, but are not required to receive,&#xD;
                  biologic/targeted (non-cytotoxic) therapy as part of their primary treatment&#xD;
                  regimen&#xD;
&#xD;
               -  Patients must have NOT received any biologic/targeted (non-cytotoxic) therapy&#xD;
                  targeting the VEGF and/or MET pathways for management of recurrent or persistent&#xD;
                  disease&#xD;
&#xD;
               -  For the purposes of this study, poly (adenosine diphosphate [ADP]-ribose)&#xD;
                  polymerase (PARP) inhibitors will be considered &quot;cytotoxic&quot;; patients are allowed&#xD;
                  to receive, but are not required to receive, PARP inhibitors for management of&#xD;
                  primary or recurrent/persistent disease (either alone or in combination with&#xD;
                  cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regimen when&#xD;
                  given alone&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl&#xD;
&#xD;
          -  Platelets greater than or equal to 100,000/mcl&#xD;
&#xD;
          -  Hemoglobin greater than or equal to 9 g/dL&#xD;
&#xD;
          -  Prothrombin time (PT) such that international normalized ratio (INR) is less than or&#xD;
             equal to 1.3 x institutional upper limit of normal (ULN)&#xD;
&#xD;
          -  Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN&#xD;
&#xD;
          -  Creatinine less than or equal to 1.5 x ULN&#xD;
&#xD;
          -  Phosphorus, corrected calcium, magnesium and potassium greater than or equal to&#xD;
             institutional lower limit of normal (LLN)&#xD;
&#xD;
          -  Urine protein creatinine (UPC) ratio must be &lt; 1.0 gm; if UPC ratio &gt;= 1, collection&#xD;
             of 24-hour urine measurement of urine protein is recommended&#xD;
&#xD;
          -  Bilirubin less than or equal to 1.5 x ULN&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal&#xD;
             to 3 x ULN&#xD;
&#xD;
          -  Alkaline phosphatase less than or equal to 2.5 x ULN&#xD;
&#xD;
          -  Albumin greater than or equal to 2.8 g/dL&#xD;
&#xD;
          -  Lipase less than or equal to 2 x ULN&#xD;
&#xD;
          -  No radiologic or clinical evidence of pancreatitis&#xD;
&#xD;
          -  Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of&#xD;
             hypothyroidism and/or hyperthyroidism is allowed&#xD;
&#xD;
          -  Neuropathy (sensory and motor) less than or equal to grade 1&#xD;
&#xD;
          -  Patients of childbearing potential must have a negative pregnancy test prior to the&#xD;
             study entry and be practicing an effective form of contraception; sexually active&#xD;
             subjects must agree to use medically accepted barrier methods of contraception (e.g.,&#xD;
             male or female condom) during the course of the study and for 4 months after the last&#xD;
             dose of study drug, even if oral contraceptives are also used; all subjects of&#xD;
             reproductive potential must agree to use both a barrier method and a second method of&#xD;
             birth control during the course of the study and for 4 months after the last dose of&#xD;
             study drug; pregnant women are excluded from this study&#xD;
&#xD;
          -  Patients must have signed an approved informed consent and authorization permitting&#xD;
             the release of personal health information&#xD;
&#xD;
          -  Patients must meet pre-entry requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have had previous treatment with cabozantinib; patients who have received&#xD;
             previous treatment with weekly paclitaxel for recurrent or persistent disease&#xD;
&#xD;
          -  Patients with a history of other invasive malignancies, with the exception of&#xD;
             non-melanoma skin cancer and other specific malignancies, are excluded if there is any&#xD;
             evidence of other malignancy being present within the last three years; patients are&#xD;
             also excluded if their previous cancer treatment contraindicates this protocol therapy&#xD;
&#xD;
          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity&#xD;
             or pelvis or thoracic cavity within the last three years are excluded; prior radiation&#xD;
             for localized cancer of the breast, head and neck, or skin is permitted, provided that&#xD;
             it was completed more than three years prior to registration, and the patient remains&#xD;
             free of recurrent or metastatic disease&#xD;
&#xD;
          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER&#xD;
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within&#xD;
             the last three years are excluded; patients may have received prior adjuvant&#xD;
             chemotherapy for localized breast cancer, provided that it was completed more than&#xD;
             three years prior to registration, and the patient remains free of recurrent or&#xD;
             metastatic disease&#xD;
&#xD;
          -  Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic&#xD;
             greater than 90 mm Hg despite antihypertensive medications&#xD;
&#xD;
          -  Myocardial infarction or unstable angina within 6 months prior to registration&#xD;
&#xD;
          -  New York Heart Association (NYHA) class II or greater congestive heart failure&#xD;
&#xD;
          -  History of serious ventricular arrhythmia (i.e., ventricular tachycardia or&#xD;
             ventricular fibrillation) or serious cardiac arrhythmia requiring medication; this&#xD;
             does not include asymptomatic atrial fibrillation with controlled ventricular rate&#xD;
&#xD;
          -  Any history of congenital long QT syndrome&#xD;
&#xD;
          -  The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) &gt;&#xD;
             500 ms within 28 days before randomization; note: if initial QTcF is found to be &gt; 500&#xD;
             ms, two additional electrocardiogram (EKGs) separated by at least 3 minutes should be&#xD;
             performed; if the average of these three consecutive results for QTcF is =&lt; 500 ms,&#xD;
             the subject meets eligibility in this regard&#xD;
&#xD;
          -  Patients with serious non-healing wound, ulcer, or bone fracture within 28 days before&#xD;
             treatment&#xD;
&#xD;
          -  Patients with history of organ transplant&#xD;
&#xD;
          -  Patients with active bleeding or pathologic conditions that carry high risk of&#xD;
             bleeding, such as known bleeding disorder, coagulopathy, or tumor involving (in&#xD;
             contact with, invading or encasing) major vessels&#xD;
&#xD;
          -  Patients who have experienced any of the following:&#xD;
&#xD;
               -  Clinically-significant gastrointestinal bleeding within 6 months before the first&#xD;
                  dose of study treatment&#xD;
&#xD;
               -  Hemoptysis of &gt;= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the&#xD;
                  first dose of study treatment&#xD;
&#xD;
               -  Any other signs indicative of pulmonary hemorrhage within 3 months before the&#xD;
                  first dose of study treatment&#xD;
&#xD;
          -  Patients who have radiographic evidence of cavitating pulmonary lesion(s)&#xD;
&#xD;
          -  Patients who have tumor invading the gastrointestinal (GI) tract (esophagus, stomach,&#xD;
             small or large bowel, rectum or anus), or any evidence of endotracheal or&#xD;
             endobronchial tumor within 28 days before treatment&#xD;
&#xD;
          -  Gastrointestinal disorders, particularly those with potential risk of perforation or&#xD;
             fistula formation including:&#xD;
&#xD;
               -  Any of the following within 28 days of registration&#xD;
&#xD;
                    -  Intra-abdominal tumor/metastases invading GI mucosa&#xD;
&#xD;
                    -  Active peptic ulcer disease&#xD;
&#xD;
                    -  Inflammatory bowel disease (including ulcerative colitis and Crohn's&#xD;
                       disease), diverticulitis, cholecystitis, symptomatic cholangitis or&#xD;
                       appendicitis&#xD;
&#xD;
                    -  Malabsorption syndrome&#xD;
&#xD;
               -  Any of the following within 6 months of registration&#xD;
&#xD;
                    -  Abdominal fistula&#xD;
&#xD;
                    -  Gastrointestinal perforation&#xD;
&#xD;
                    -  Bowel obstruction or gastric outlet obstruction; note: patients requiring&#xD;
                       drainage gastrostomy (e.g., percutaneous endoscopic gastrostomy [PEG] tube)&#xD;
                       and/or parenteral hydration and/or nutrition are not eligible&#xD;
&#xD;
                    -  Intra-abdominal abscess; note: complete resolution of an intra-abdominal&#xD;
                       abscess must be confirmed prior to registration even if the abscess occurred&#xD;
                       more than 6 months prior to registration&#xD;
&#xD;
          -  Patients with history or evidence upon physical examination of central nervous system&#xD;
             (CNS) disease, including primary brain tumor, seizures which are not controlled with&#xD;
             non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or&#xD;
             history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or&#xD;
             subarachnoid hemorrhage within six months prior to the first date of study treatment&#xD;
&#xD;
          -  The subject requires chronic concomitant treatment of strong cytochrome P450, family&#xD;
             3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin,&#xD;
             carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort)&#xD;
&#xD;
          -  Patients who are unable or unwilling to swallow tablets&#xD;
&#xD;
          -  Patients who are pregnant or nursing&#xD;
&#xD;
          -  The subject requires concomitant treatment, in therapeutic doses, with anti-coagulants&#xD;
             such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors&#xD;
             or antiplatelet agents (i.e. clopidogrel); low dose aspirin (=&lt; 81 mg/day) low-dose&#xD;
             warfarin (=&lt; 1 mg/day) and prophylactic low molecular weight heparin are permitted&#xD;
&#xD;
          -  Major surgery within 3 months of the first dose of cabozantinib if there were no wound&#xD;
             healing complications or within 6 months of the first dose of cabozantinib if there&#xD;
             were wound complications&#xD;
&#xD;
          -  Minor surgery within 1 month of the first dose of cabozantinib if there were no wound&#xD;
             healing complications or within 3 months of the first dose of cabozantinib if there&#xD;
             were wound complications&#xD;
&#xD;
          -  Patients with concurrent uncompensated hypothyroidism or thyroid dysfunction within 7&#xD;
             days before the first dose of study treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ursula A Matulonis</last_name>
    <role>Principal Investigator</role>
    <affiliation>NRG Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Alabama Mitchell Cancer Institute</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Joseph Medical Center/Disney Family Cancer Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Medical Center-Concord Campus</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles County-USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gynecologic Oncology Associates-Newport Beach</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</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 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>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Hospital</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Medical Center-Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</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>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</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>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</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>Sudarshan K Sharma MD Limited-Gynecologic Oncology</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Regional Health Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</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>Saint Vincent Hospital and Health Care Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</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 PC - Ames</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic PC-Boone</name>
      <address>
        <city>Boone</city>
        <state>Iowa</state>
        <zip>50036</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>Medical Oncology and Hematology Associates-Laurel</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</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>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>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic PC-Jefferson</name>
      <address>
        <city>Jefferson</city>
        <state>Iowa</state>
        <zip>50129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic PC-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-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>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>Via Christi Regional Medical Center</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>Woman's Hospital</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center-Bramhall Campus</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center- Scarborough Campus</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital of Cecil County</name>
      <address>
        <city>Elkton</city>
        <state>Maryland</state>
        <zip>21921</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Health Care</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01605</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>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>Saint Dominic-Jackson Memorial Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</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>Freeman Health System</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Research for the Ozarks NCORP</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's Cancer Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</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>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laura and Isaac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</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>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center/Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hanover Regional Medical Center/Zimmer Cancer Center</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Bismarck Medical Center</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58501</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 Akron City Hospital/Cooper Cancer Center</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>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>Cleveland Clinic Cancer Center/Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</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>Miami Valley Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</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>Lancaster Radiation Oncology</name>
      <address>
        <city>Lancaster</city>
        <state>Ohio</state>
        <zip>43130</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>Hillcrest Hospital Cancer Center</name>
      <address>
        <city>Mayfield Heights</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UH Seidman Cancer Center at Lake Health Mentor Campus</name>
      <address>
        <city>Mentor</city>
        <state>Ohio</state>
        <zip>44060</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>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>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>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cancer Specialists and Research Institute-Tulsa</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Memorial Hospital</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women and Infants Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</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>The Don and Sybil Harrington Cancer Center</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor All Saints Medical Center at Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndon Baines Johnson General Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77026-1967</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Medical Group PC</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Bremerton</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison Medical Center</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer Partnership</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skagit Valley Hospital Regional Cancer Care Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Washington</state>
        <zip>98274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Poulsbo</name>
      <address>
        <city>Poulsbo</city>
        <state>Washington</state>
        <zip>98370</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Gynecology Specialists</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-First Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122-4307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympic Medical Cancer Care Center</name>
      <address>
        <city>Sequim</city>
        <state>Washington</state>
        <zip>98384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Northwest - Spokane South</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockwood Cancer Treatment Center-DHEC-Downtown</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Tacoma General Hospital</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Mary Regional Cancer Center</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>99362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenatchee Valley Hospital and Clinics</name>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</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>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</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>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>ProHealth D N Greenwald Center</name>
      <address>
        <city>Mukwonago</city>
        <state>Wisconsin</state>
        <zip>53149</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>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>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>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>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>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>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 Clinic - Weston Center</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</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>February 2020</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>June 26, 2019</results_first_submitted>
  <results_first_submitted_qc>February 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2020</results_first_posted>
  <last_update_submitted>February 28, 2020</last_update_submitted>
  <last_update_submitted_qc>February 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>111 patients were enrolled from November 6, 2012 to May 5, 2014</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cabozantinib</title>
          <description>Cabozantinib 60 mg oral daily continously</description>
        </group>
        <group group_id="P2">
          <title>Paclitaxel</title>
          <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled participants</population>
      <group_list>
        <group group_id="B1">
          <title>Cabozantinib</title>
          <description>Cabozantinib 60 mg oral daily continously</description>
        </group>
        <group group_id="B2">
          <title>Paclitaxel</title>
          <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="111"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>20-29 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-39 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40-49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-59 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60-69 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>70-79 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=80 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="57"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Event Free Survival</title>
        <description>Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
        <time_frame>The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks</time_frame>
        <population>Enrolled Patients</population>
        <group_list>
          <group group_id="O1">
            <title>Cabozantinib</title>
            <description>Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel</title>
            <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>Event Free Survival</title>
          <description>Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
          <population>Enrolled 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="57"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.48" lower_limit="2.79" upper_limit="4.07"/>
                    <measurement group_id="O2" value="4.96" lower_limit="3.71" upper_limit="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or Higher Adverse Events by Type</title>
        <description>Toxicities will be characterized by their frequency and severity, grade 3 and above.</description>
        <time_frame>Up to 30 days after completion of study treatment</time_frame>
        <population>Eligible and Treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Grade 3 and Above on Cabozantinib</title>
            <description>Grade 3 and above toxicities for participants on Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Grade 3 and Above on Paclitaxel</title>
            <description>Grade 3 toxicities for participants on Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Higher Adverse Events by Type</title>
          <description>Toxicities will be characterized by their frequency and severity, grade 3 and above.</description>
          <population>Eligible and Treated participants</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolism/nutrition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculoskeletal/connective tissue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nervous System</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal/Urinary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory/thoracic/mediastinal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin/subcutaneous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vascular disorders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response, Assessed According to RECIST Version 1.1</title>
        <description>Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
        <time_frame>CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cabozantinib</title>
            <description>Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel</title>
            <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>Response, Assessed According to RECIST Version 1.1</title>
          <description>Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
          <population>All enrolled participants</population>
          <units>percentage 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="57"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.02" lower_limit="2.4" upper_limit="15.3"/>
                    <measurement group_id="O2" value="24.07" lower_limit="14.9" upper_limit="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With CA125 Response.</title>
        <description>Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
        <time_frame>Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.</time_frame>
        <population>Participants evaluable by CA125</population>
        <group_list>
          <group group_id="O1">
            <title>Cabozantinib</title>
            <description>Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel</title>
            <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With CA125 Response.</title>
          <description>Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
          <population>Participants evaluable by CA125</population>
          <units>percentage 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="34"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" lower_limit="16.9" upper_limit="44.8"/>
                    <measurement group_id="O2" value="58.6" lower_limit="41.7" upper_limit="74.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.</description>
        <time_frame>The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Cabozantinib</title>
            <description>Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel</title>
            <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.</description>
          <population>All enrolled participants</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="12.3" upper_limit="NA">Upper limit of confidence interval has not been reached</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="16" upper_limit="NA">The median and upper limit of confidence interval has not been reached</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Estimate the Response Duration Among Patients Who Respond.</title>
        <description>The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
        <time_frame>From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.</time_frame>
        <population>Patients who respond.</population>
        <group_list>
          <group group_id="O1">
            <title>Cabozantinib</title>
            <description>Cabozantinib 60 mg oral daily continously</description>
          </group>
          <group group_id="O2">
            <title>Paclitaxel</title>
            <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
          </group>
        </group_list>
        <measure>
          <title>To Estimate the Response Duration Among Patients Who Respond.</title>
          <description>The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.&quot;,</description>
          <population>Patients who respond.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="0.1" upper_limit="4.3"/>
                    <measurement group_id="O2" value="7.4" lower_limit="3.5" upper_limit="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>c-Met Expression</title>
        <time_frame>Baseline</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>c-MET Copy Number</title>
        <time_frame>Baseline</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During study treatment through 30 days after treatment ends, an average of 2.5 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cabozantinib</title>
          <description>Cabozantinib 60 mg oral daily continously</description>
        </group>
        <group group_id="E2">
          <title>Paclitaxel</title>
          <description>Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="25" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Small Intestinal Perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mucositis Oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Anal Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ileal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms Benign, Malignant And Unspecified (Incl</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Memory Impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </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="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="55" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="50"/>
              </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="23" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block First Degree</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cardiac Disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ventricular Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Endocrine Disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Watering Eyes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blurred Vision</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dry Eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Eyelid Function Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Enterovesical Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rectal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oral Dysesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Obstruction Gastric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mucositis Oral</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lower Gastrointestinal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rectal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fecal Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Esophageal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Localized Edema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Flu Like Symptoms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Edema Trunk</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Gait Disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Tooth Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Stoma Site Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rhinitis Infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Otitis Media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Papulopustular Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Mucosal Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Esophageal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Catheter Related Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Enterocolitis Infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bladder Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Anorectal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight Loss</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Weight Gain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Serum Amylase Increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Inr Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ggt Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>White Blood Cell Decreased</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Activated Partial Thromboplastin Time Prolonged</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Generalized Muscle Weakness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Flank Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Chest Wall Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Buttock Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms Benign, Malignant And Unspecified (Incl</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Peripheral Motor Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Memory Impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Movements Involuntary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Concentration Impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cognitive Disturbance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Personality Change</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Libido Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Euphoria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urine Discoloration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Tract Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Tract Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hemoglobinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cystitis Noninfective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal Hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pelvic Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Vaginal Discharge</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, Thoracic And Mediastinal Disorders -</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Voice Alteration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sore Throat</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Sinus Disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Postnasal Drip</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pharyngolaryngeal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pleuritic Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Bronchial Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Allergic Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin And Subcutaneous Tissue Disorders - Other</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Skin Ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Skin Hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rash Acneiform</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Palmar-Plantar Erythrodysesthesia Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Pain Of Skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Skin Hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nail Loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Nail Discoloration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Erythema Multiforme</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Lymphedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hot Flashes</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="50"/>
              </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>Linda Gedeon on behalf of Michael Sill, PhD.</name_or_title>
      <organization>NRG Oncology</organization>
      <phone>716-845-1169</phone>
      <email>lgedeon@gogstats.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716715
org study id: NCI-2012-02058
secondary id: NCI-2012-02058
secondary id: GOG-0186K
secondary id: S13-00312
secondary id: GOG-0186K
secondary id: GOG-0186K
secondary id: U10CA180868
secondary id: U10CA027469
nct id: NCT01716715
lead sponsor: 
has dmc: Yes
This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel
      works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube,
      or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells
      by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or
      paclitaxel is more effective at treating patients with persistent or recurrent epithelial
      ovarian, fallopian tube, or primary peritoneal cavity cancer.
PRIMARY OBJECTIVES:

      I. To assess the activity of cabozantinib (cabozantinib-s-malate) relative to weekly
      paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary
      peritoneal cancer with a log-rank test assessing progression-free survival (PFS) at 3.68
      months (approximately pre-cycle 5) and 7.36 months (approximately pre-cycle 9).

      SECONDARY OBJECTIVES:

      I. To determine the frequency and severity of adverse events as assessed by Common
      Terminology Criteria for Adverse Events (CTCAE).

      II. To estimate and compare the proportion of patients responding to therapy by Response
      Evaluation Criteria for Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the
      overall survival (OS), and the duration of response in each arm.

      TERTIARY OBJECTIVES:

      I. To retrospectively correlate c-met proto-oncogene (MET) expression with overall outcome.

      II. To retrospectively correlate c-MET copy number with overall outcome.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28.

      ARM II: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15.

      In both arms, 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: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Event Free Survival
time frame: The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks
description: Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
measure: Number of Participants With Grade 3 or Higher Adverse Events by Type
time frame: Up to 30 days after completion of study treatment
description: Toxicities will be characterized by their frequency and severity, grade 3 and above.
measure: Response, Assessed According to RECIST Version 1.1
time frame: CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years
description: Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
measure: Percentage of Participants With CA125 Response.
time frame: Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.
description: Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
measure: Overall Survival
time frame: The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.
description: The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.
measure: To Estimate the Response Duration Among Patients Who Respond.
time frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.
description: The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
measure: c-Met Expression
time frame: Baseline
measure: c-MET Copy Number
time frame: Baseline
arm group label: Arm I (cabozantinib-s-malate)
arm group type: Experimental
description: Patients receive cabozantinib-s-malate PO QD on days 1-28.
arm group label: Arm II (paclitaxel)
arm group type: Experimental
description: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15.
intervention type: Drug
intervention name: Cabozantinib S-malate
description: Given PO
arm group label: Arm I (cabozantinib-s-malate)
other name: BMS-907351
other name: Cabometyx
other name: Cometriq
other name: XL184
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (cabozantinib-s-malate)
arm group label: Arm II (paclitaxel)
intervention type: Drug
intervention name: Paclitaxel
description: Given IV
arm group label: Arm II (paclitaxel)
other name: Anzatax
other name: Asotax
other name: Bristaxol
other name: Praxel
other name: Taxol
other name: Taxol Konzentrat
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ursula A Matulonis
role: Principal Investigator
affiliation: NRG Oncology
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Recurrence
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 