<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/NCT01673386</url>
  </required_header>
  <id_info>
    <org_study_id>AV-951-12-205</org_study_id>
    <nct_id>NCT01673386</nct_id>
  </id_info>
  <brief_title>A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC</brief_title>
  <acronym>TAURUS</acronym>
  <official_title>A Phase 2 Randomized, Double-Blind, Crossover, Controlled, Multi-Center Subject Preference Study of Tivozanib Hydrochloride Versus Sunitinib in the Treatment of Subjects With Metastatic Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AVEO Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AVEO Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and&#xD;
      sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for&#xD;
      Renal Cell Carcinoma (RCC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride&#xD;
      and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for&#xD;
      Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0&#xD;
      vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2&#xD;
      treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in&#xD;
      between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and&#xD;
      sunitinib sequentially. The study is designed to compare subject treatment preference, as&#xD;
      well as overall safety and tolerability, frequency of dose modifications and kidney-specific&#xD;
      health outcomes/QoL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With AEs and SAEs</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>Number of subjects with serious and non-serious adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Dose Reductions</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Dose Interruptions</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Grade 3/4 Hematology Abnormalities</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Grade 3/4 Chemistry Abnormalities</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Grade 3/4 Coagulation Abnormalities</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Grade 3/4 Urinalysis Abnormalities</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Grade 3/4 Thyroid Function Abnormalities</measure>
    <time_frame>Up to 25 weeks</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)</measure>
    <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)</measure>
    <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)</measure>
    <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)</measure>
    <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
    <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Metastatic Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Tivozanib Hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sunitinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tivozanib</intervention_name>
    <arm_group_label>Tivozanib Hydrochloride</arm_group_label>
    <other_name>Tivozanib Hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sunitinib</intervention_name>
    <arm_group_label>Sunitinib</arm_group_label>
    <other_name>Sutent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unresectable mRCC&#xD;
&#xD;
          -  Histologically or cytologically confirmed RCC of any histology&#xD;
&#xD;
          -  Subjects with or without prior nephrectomy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any prior systemic therapy for treatment of mRCC (including investigational or&#xD;
             licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of&#xD;
             rapamycin [mTOR] inhibitors)&#xD;
&#xD;
          -  Central nervous system malignancies or metastases&#xD;
&#xD;
          -  Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or&#xD;
             coagulation disorders&#xD;
&#xD;
          -  Significant serum chemistry or urinalysis abnormalities&#xD;
&#xD;
          -  Significant cardiovascular disease, including symptomatic left ventricular ejection&#xD;
             fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled&#xD;
             hypertension, myocardial infarction or severe angina within 6 months prior to&#xD;
             administration of first dose of study drug, history of class III or IV congestive&#xD;
             heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or&#xD;
             coronary or peripheral bypass graft within 6 months of screening&#xD;
&#xD;
          -  Corrected QT interval (QTc) of &gt;480 msec using Bazett's formula&#xD;
&#xD;
          -  Currently active second primary malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Needle, MD</last_name>
    <role>Study Chair</role>
    <affiliation>AVEO Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <zip>31701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Swansea</city>
        <state>Wales</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.aveooncology.com/</url>
    <description>Aveo Pharmaceuticals, Inc. official web page</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>July 7, 2020</results_first_submitted>
  <results_first_submitted_qc>October 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2020</results_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tivozanib hydrochloride</keyword>
  <keyword>renal cell carcinoma</keyword>
  <keyword>subject preference</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sunitinib</mesh_term>
    <mesh_term>Tivozanib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All screening assessments were performed within 28 days prior to the first dose of study drug. All subjects were recruited as per the inclusion and exclusion criteria.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Tivozanib First, Then Sunitinib</title>
          <description>Subject randomized to this arm received 1.5 mg oral tivozanib hydrochloride (drug 1) daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib (drug 2) daily on a 4 weeks on/2 weeks off schedule for 12 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Sunitinib First, Then Tivosanib</title>
          <description>Subject randomized to this arm received 50 mg oral sunitinib (drug 1) daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride (drug 2) daily on a 3 weeks on/1 week off schedule for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2">Of 2 subjects, 1 subject discontinued tivozanib early, completed planned treatment with sunitinib.</participants>
                <participants group_id="P2" count="4">Of 4 subjects, 3 subjects discontinued sunitinib early, completed planned treatment with tivozanib.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Subjects randomized to Arm 1, received 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule for 12 weeks (3 cycles) followed by 50 mg oral sunitinib daily on a 4 week on/2 week off schedule for 12 weeks (2 cycles). Subjects randomized to Arm 2, received 50 mg oral sunitinib daily on a 4 week on/2 weeks off schedule for 12 weeks followed by 1.5 mg oral tivozanib daily on a 3 week on/1 week off schedule.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" lower_limit="38" upper_limit="80"/>
                  </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With AEs and SAEs</title>
        <description>Number of subjects with serious and non-serious adverse events.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events).</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With AEs and SAEs</title>
          <description>Number of subjects with serious and non-serious adverse events.</description>
          <population>Descriptive statistical analyses were performed for a limited set of data (disposition, demographics, and adverse events).</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="38"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one treatment-related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one serious AE (SAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one treatment-related SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one AE leading to drug withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least one AE with outcome of death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Dose Reductions</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Dose Reductions</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Dose Interruptions</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Dose Interruptions</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Grade 3/4 Hematology Abnormalities</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Grade 3/4 Hematology Abnormalities</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Grade 3/4 Chemistry Abnormalities</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Grade 3/4 Chemistry Abnormalities</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Grade 3/4 Coagulation Abnormalities</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Grade 3/4 Coagulation Abnormalities</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Grade 3/4 Urinalysis Abnormalities</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Grade 3/4 Urinalysis Abnormalities</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Grade 3/4 Thyroid Function Abnormalities</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Up to 25 weeks</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Grade 3/4 Thyroid Function Abnormalities</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)</title>
        <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
        <time_frame>Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment</time_frame>
        <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Tivozanib</title>
            <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
          </group>
          <group group_id="O2">
            <title>Sunitinib</title>
            <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)</title>
          <description>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</description>
          <population>The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Collected from the time of signing the Informed Consent Form until 30 days after permanent treatment discontinuation at Week 25 (2 sequential 12-week treatment periods with a 1-week washout period). The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.</time_frame>
      <desc>Serious treatment-emergent adverse events and treatment-emergent adverse events in Safety (SAF) Population was reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Tivozanib</title>
          <description>Tivozanib hydrochloride 1.5 mg was administered orally to the randomized subjects first in arm 1 and second in arm 2.</description>
        </group>
        <group group_id="E2">
          <title>Sunitinib</title>
          <description>Sunitinib 50 mg was administered orally to the randomized subjects first in arm 2 and second in arm 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.1)</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="6" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_vocab>MedDRA (14.1)</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="35" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oral dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </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="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hair colour changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Yellow skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>AVEO Pharmaceuticals, Inc.</organization>
      <phone>857-400-0101</phone>
      <email>Clinical@aveooncology.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673386
org study id: AV-951-12-205
nct id: NCT01673386
lead sponsor: 
collaborator: 
has dmc: No
Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and
      sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for
      Renal Cell Carcinoma (RCC).
This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride
      and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for
      Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0
      vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2
      treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in
      between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and
      sunitinib sequentially. The study is designed to compare subject treatment preference, as
      well as overall safety and tolerability, frequency of dose modifications and kidney-specific
      health outcomes/QoL.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of Subjects Who Prefer Tivozanib Hydrochloride or Sunitinib
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With AEs and SAEs
time frame: Up to 25 weeks
description: Number of subjects with serious and non-serious adverse events.
measure: Number of Subjects With Dose Reductions
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Dose Interruptions
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Grade 3/4 Hematology Abnormalities
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Grade 3/4 Chemistry Abnormalities
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Grade 3/4 Coagulation Abnormalities
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Grade 3/4 Urinalysis Abnormalities
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Number of Subjects With Grade 3/4 Thyroid Function Abnormalities
time frame: Up to 25 weeks
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
time frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Change From Baseline in FACT Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS)
time frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Diarrhea (FACT-D)
time frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
measure: Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D)
time frame: Baseline, Weeks 1, 4, 10, 14, 17, 23, and End of Treatment
description: The study was terminated prior to completing enrollment; due to low enrollment, no data was collected for this outcome measure.
arm group label: Tivozanib Hydrochloride
arm group type: Experimental
description: 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks, followed by 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks.
arm group label: Sunitinib
arm group type: Active Comparator
description: 50 mg oral sunitinib daily on a 4 weeks on/2 weeks off schedule for 12 weeks, followed by 1.5 mg oral tivozanib hydrochloride daily on a 3 weeks on/1 week off schedule for 12 weeks.
intervention type: Drug
intervention name: Tivozanib
arm group label: Tivozanib Hydrochloride
other name: Tivozanib Hydrochloride
intervention type: Drug
intervention name: Sunitinib
arm group label: Sunitinib
other name: Sutent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Needle, MD
role: Study Chair
affiliation: AVEO Pharmaceuticals, Inc.
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country: Belgium
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
url: http://www.aveooncology.com/
description: Aveo Pharmaceuticals, Inc. official web page
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Sunitinib
mesh term: Tivozanib
sharing ipd: No
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The Sponsor terminated Study AV-951-12-205 before enrollment was completed, following the negative decision of the US FDA.
point of contact: 