<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/NCT01697462</url>
  </required_header>
  <id_info>
    <org_study_id>ML22585</org_study_id>
    <nct_id>NCT01697462</nct_id>
  </id_info>
  <brief_title>An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)</brief_title>
  <official_title>Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This prospective observational study will evaluate the safety and efficacy of Xeloda&#xD;
      (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer.&#xD;
      Patients will be followed until disease progression or unacceptable toxicity occurs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to end of study (up to 42 months)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Progression</measure>
    <time_frame>Baseline to progressive disease or death (up to 42 months)</time_frame>
    <description>Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Baseline to progressive disease or death (up to 42 months)</time_frame>
    <description>PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hand-Foot Syndrome (HFS)</measure>
    <time_frame>Baseline up to end of study (up to 42 months)</time_frame>
    <description>HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">258</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with metastatic colorectal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Metastatic colorectal cancer&#xD;
&#xD;
          -  Receiving Xeloda according to registered indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not eligible for Xeloda treatment according to the Summary of Product&#xD;
             Characteristics&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>NIS</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>December 16, 2015</results_first_submitted>
  <results_first_submitted_qc>December 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 26, 2016</results_first_posted>
  <last_update_submitted>December 16, 2015</last_update_submitted>
  <last_update_submitted_qc>December 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>mCRC Participants</title>
          <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="258"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="181"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population included all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>mCRC Participants</title>
          <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="258"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.38" spread="10.24"/>
                  </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="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.</description>
        <time_frame>Baseline up to end of study (up to 42 months)</time_frame>
        <population>Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>mCRC Participants</title>
            <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.</description>
          <population>Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Progression</title>
        <description>Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.</description>
        <time_frame>Baseline to progressive disease or death (up to 42 months)</time_frame>
        <population>ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>mCRC Participants</title>
            <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Progression</title>
          <description>Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.</description>
          <population>ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.</description>
        <time_frame>Baseline to progressive disease or death (up to 42 months)</time_frame>
        <population>ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>mCRC Participants</title>
            <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.</description>
          <population>ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="3.64" upper_limit="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hand-Foot Syndrome (HFS)</title>
        <description>HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.</description>
        <time_frame>Baseline up to end of study (up to 42 months)</time_frame>
        <population>ITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>mCRC Participants</title>
            <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hand-Foot Syndrome (HFS)</title>
          <description>HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.</description>
          <population>ITT population.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to end of study (up to 42 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>mCRC Participants</title>
          <description>Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </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="2" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="132" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="258"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="258"/>
              </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="79" subjects_at_risk="258"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-LaRoche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT01697462
org study id: ML22585
nct id: NCT01697462
lead sponsor: 
This prospective observational study will evaluate the safety and efficacy of Xeloda
      (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer.
      Patients will be followed until disease progression or unacceptable toxicity occurs.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to end of study (up to 42 months)
description: An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
measure: Percentage of Participants With Disease Progression
time frame: Baseline to progressive disease or death (up to 42 months)
description: Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.
measure: Progression-Free Survival (PFS)
time frame: Baseline to progressive disease or death (up to 42 months)
description: PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.
measure: Number of Participants With Hand-Foot Syndrome (HFS)
time frame: Baseline up to end of study (up to 42 months)
description: HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
country: Serbia
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 