<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/NCT01732783</url>
  </required_header>
  <id_info>
    <org_study_id>20120100</org_study_id>
    <nct_id>NCT01732783</nct_id>
  </id_info>
  <brief_title>Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients</brief_title>
  <official_title>Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in&#xD;
      combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog&#xD;
      (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX&#xD;
      or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received&#xD;
      first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2012</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</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>Total Number of Panitumumab Infusions</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Dose of Panitumumab</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Dose of Panitumumab</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Panitumumab Exposure</measure>
    <time_frame>12 months</time_frame>
    <description>Duration of exposure is the time from the first to the last panitumumab infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Interval Between Panitumumab Infusions</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Panitumumab Dose Reduction</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Panitumumab Dose Delay</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for Discontinuation of Panitumumab</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of Exposure of All Concomitant Chemotherapy</measure>
    <time_frame>12 months</time_frame>
    <description>Duration of exposure is the time from the first date to the last date of chemotherapy administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Hospitalization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Types of Hospital Visit</measure>
    <time_frame>12 months</time_frame>
    <description>Participants may have had more than one type of hospital visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Hospital Stay</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for Hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>Participants may have had more than one hospital visit and/or reason for a hospital visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With an Overall Response</measure>
    <time_frame>12 months</time_frame>
    <description>Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Resectability</measure>
    <time_frame>12 months</time_frame>
    <description>Resectability denotes whether a participant became resectable during the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Post-Panitumumab Anti-cancer Treatment</measure>
    <time_frame>12 months</time_frame>
    <description>Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">213</enrollment>
  <condition>Wild-type RAS Metastatic Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Metastatic Colorectal Cancer</arm_group_label>
    <description>Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Panitumumab + Chemotherapy</intervention_name>
    <description>Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.</description>
    <arm_group_label>Metastatic Colorectal Cancer</arm_group_label>
    <other_name>Vectibix®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All treatment centres (inpatient and outpatient) with a focus on treating patients with&#xD;
        mCRC. Centres will be selected to represent academic, oncology and specialist settings and&#xD;
        to provide geographical diversity in France and Germany.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subject is ≥ 18 years of age at date of enrolment&#xD;
&#xD;
          -  Histologically or cytologically confirmed carcinoma of colon or rectum&#xD;
&#xD;
          -  Subject with metastatic carcinoma of colon or rectum&#xD;
&#xD;
          -  Confirmed wild-type RAS status of tumour&#xD;
&#xD;
          -  Subjects whose care will be managed primarily by the enrolling physician and/ or all&#xD;
             records will be available&#xD;
&#xD;
          -  Tumour assessment (ie, computed tomography [CT]/magnetic resonance imaging [MRI])&#xD;
             within 12 weeks (84 days) prior to first Vectibix® infusion.&#xD;
&#xD;
          -  Subjects treated with at least one infusion of Vectibix® in combination with&#xD;
             chemotherapy a maximum of 84 days before entering study: first-line in combination&#xD;
             with FOLFOX (folinic acid, leucovorin, fluorouracil [5FU], oxaliplatin) or second-line&#xD;
             in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects&#xD;
             who have received first-line fluoropyrimidine-based chemotherapy (excluding&#xD;
             irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information&#xD;
&#xD;
          -  Subject or subject's legally acceptable representative has provided informed consent&#xD;
             (for countries where required per local regulations)&#xD;
&#xD;
          -  Subjects treated with Vectibix® in accordance with the current version of the Summary&#xD;
             of Product Characteristics (SmPC)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Ongoing or planned concurrent participation in any clinical study involving&#xD;
             Investigational Product that has not been approved by the European Medicines Agency&#xD;
             for any indication&#xD;
&#xD;
          -  Ongoing or planned concurrent participation in any clinical study where the dosing of&#xD;
             Vectibix® is determined by the protocol (participation in clinical trials on an&#xD;
             approved drug and observational trials are permitted but these cannot mandate how mCRC&#xD;
             should be treated)&#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>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>November 22, 2017</results_first_submitted>
  <results_first_submitted_qc>November 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 20, 2018</results_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wild-type RAS</keyword>
  <keyword>Metastatic Colorectal Cancer</keyword>
  <keyword>Vectibix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panitumumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in France and Germany between 10 December 2012 and 30 November 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Panitumumab + FOLFOX First-line</title>
          <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
        </group>
        <group group_id="P2">
          <title>Panitumumab + FOLFIRI Second-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
        </group>
        <group group_id="P3">
          <title>Panitumumab + FOLFIRI First-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">Completed 12-month observation period.</participants>
                <participants group_id="P2" count="5">Completed 12-month observation period.</participants>
                <participants group_id="P3" count="2">Completed 12-month observation period.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="135"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Discontinued Panitumumab Treatment</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative Decision</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Panitumumab + FOLFOX First-line</title>
          <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
        </group>
        <group group_id="B2">
          <title>Panitumumab + FOLFIRI Second-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
        </group>
        <group group_id="B3">
          <title>Panitumumab + FOLFIRI First-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="164"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="213"/>
          </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="64.8" spread="9.6"/>
                    <measurement group_id="B2" value="65.8" spread="9.9"/>
                    <measurement group_id="B3" value="69.0" spread="7.6"/>
                    <measurement group_id="B4" value="65.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 65 to &lt; 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 75 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="31"/>
                  </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="52"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about &gt; 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair &gt; 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 - Fully active</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 - Restricted but ambulatory</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 - Ambulatory but unable to work</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Colorectal Cancer Type</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Colon, left of mid-line</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Colon, right of mid-line</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Colon</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rectum</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Metastatic Colorectal Cancer Status</title>
          <description>Synchronous colorectal neoplasias are defined as 2 or more primary tumors identified in the same patient and at the same time.&#xD;
Metachronous refers to lesions that appear after diagnosis of the primary lesion.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Synchronous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Metachronous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Metastatic Disease Lesion Sites</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Liver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lung</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Number of Panitumumab Infusions</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Panitumumab Infusions</title>
          <units>infusions</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="6.0" upper_limit="16.0"/>
                    <measurement group_id="O2" value="10.0" lower_limit="6.0" upper_limit="16.0"/>
                    <measurement group_id="O3" value="8.0" lower_limit="4.0" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cumulative Dose of Panitumumab</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Dose of Panitumumab</title>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4262.5" lower_limit="2311.5" upper_limit="6902.5"/>
                    <measurement group_id="O2" value="4000.0" lower_limit="2400.0" upper_limit="6000.0"/>
                    <measurement group_id="O3" value="3782.5" lower_limit="1772.5" upper_limit="5751.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Dose of Panitumumab</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Dose of Panitumumab</title>
          <units>mg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="450.0" lower_limit="380.0" upper_limit="520.0"/>
                    <measurement group_id="O2" value="420.0" lower_limit="390.0" upper_limit="500.0"/>
                    <measurement group_id="O3" value="507.0" lower_limit="424.0" upper_limit="590.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Panitumumab Exposure</title>
        <description>Duration of exposure is the time from the first to the last panitumumab infusion</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Panitumumab Exposure</title>
          <description>Duration of exposure is the time from the first to the last panitumumab infusion</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.339" lower_limit="2.546" upper_limit="10.053"/>
                    <measurement group_id="O2" value="6.012" lower_limit="2.464" upper_limit="8.246"/>
                    <measurement group_id="O3" value="5.339" lower_limit="1.922" upper_limit="12.008"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Interval Between Panitumumab Infusions</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Interval Between Panitumumab Infusions</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt; 0 to 7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 7 to 14 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 14 to 21 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 21 to 28 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 28 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Panitumumab Dose Reduction</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Panitumumab Dose Reduction</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6" lower_limit="29.6" upper_limit="44.2"/>
                    <measurement group_id="O2" value="21.6" lower_limit="11.4" upper_limit="37.2"/>
                    <measurement group_id="O3" value="50.0" lower_limit="25.4" upper_limit="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Panitumumab Dose Delay</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Panitumumab Dose Delay</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="35.4" upper_limit="50.3"/>
                    <measurement group_id="O2" value="21.6" lower_limit="11.4" upper_limit="37.2"/>
                    <measurement group_id="O3" value="41.7" lower_limit="19.3" upper_limit="68.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Reasons for Discontinuation of Panitumumab</title>
        <time_frame>12 months</time_frame>
        <population>Participants who discontinued panitumumab while on study</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Reasons for Discontinuation of Panitumumab</title>
          <population>Participants who discontinued panitumumab while on study</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="138"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Disease progression</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Physician or Oncologist decision</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Planned surgical resection</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adverse Drug Reaction (ADR)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient request to discontinue all treatment</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adverse event</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lost to follow-up</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Patient request to discontinue panitumumab</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Duration of Exposure of All Concomitant Chemotherapy</title>
        <description>Duration of exposure is the time from the first date to the last date of chemotherapy administration.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Exposure of All Concomitant Chemotherapy</title>
          <description>Duration of exposure is the time from the first date to the last date of chemotherapy administration.</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.240" lower_limit="2.595" upper_limit="8.969"/>
                    <measurement group_id="O2" value="5.092" lower_limit="2.431" upper_limit="7.622"/>
                    <measurement group_id="O3" value="3.860" lower_limit="1.889" upper_limit="9.413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.3"/>
                    <measurement group_id="O2" value="24.3"/>
                    <measurement group_id="O3" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3"/>
                    <measurement group_id="O2" value="29.7"/>
                    <measurement group_id="O3" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Hospitalization</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Hospitalization</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Types of Hospital Visit</title>
        <description>Participants may have had more than one type of hospital visit.</description>
        <time_frame>12 months</time_frame>
        <population>Participants with at least one hospital visit</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Types of Hospital Visit</title>
          <description>Participants may have had more than one type of hospital visit.</description>
          <population>Participants with at least one hospital visit</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Outpatient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inpatient</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emergency room</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day case</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Hospital Stay</title>
        <time_frame>12 months</time_frame>
        <population>Participants with at least one hospital visit</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Hospital Stay</title>
          <population>Participants with at least one hospital visit</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" lower_limit="19.0" upper_limit="66.0"/>
                    <measurement group_id="O2" value="28.0" lower_limit="19.0" upper_limit="43.0"/>
                    <measurement group_id="O3" value="24.5" lower_limit="8.5" upper_limit="60.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reasons for Hospitalization</title>
        <description>Participants may have had more than one hospital visit and/or reason for a hospital visit.</description>
        <time_frame>12 months</time_frame>
        <population>Participants with at least one hospitalization</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Reasons for Hospitalization</title>
          <description>Participants may have had more than one hospital visit and/or reason for a hospital visit.</description>
          <population>Participants with at least one hospitalization</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mCRC related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mCRC and treatment related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With an Overall Response</title>
        <description>Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).</description>
        <time_frame>12 months</time_frame>
        <population>Participants with tumor response data post-baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Overall Response</title>
          <description>Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).</description>
          <population>Participants with tumor response data post-baseline</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" lower_limit="38.5" upper_limit="56.7"/>
                    <measurement group_id="O2" value="33.3" lower_limit="18.0" upper_limit="51.8"/>
                    <measurement group_id="O3" value="50.0" lower_limit="15.7" upper_limit="84.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Resectability</title>
        <description>Resectability denotes whether a participant became resectable during the study.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Resectability</title>
          <description>Resectability denotes whether a participant became resectable during the study.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="164"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Type of Post-Panitumumab Anti-cancer Treatment</title>
        <description>Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.</description>
        <time_frame>12 months</time_frame>
        <population>Participants who reported use of anti-cancer treatment after discontinuation of panitumumab</population>
        <group_list>
          <group group_id="O1">
            <title>Panitumumab + FOLFOX First-line</title>
            <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
          </group>
          <group group_id="O2">
            <title>Panitumumab + FOLFIRI Second-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
          </group>
          <group group_id="O3">
            <title>Panitumumab + FOLFIRI First-line</title>
            <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
          </group>
        </group_list>
        <measure>
          <title>Type of Post-Panitumumab Anti-cancer Treatment</title>
          <description>Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.</description>
          <population>Participants who reported use of anti-cancer treatment after discontinuation of panitumumab</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Chemotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radiotherapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Targeted biologics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other small molecules</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively.</time_frame>
      <desc>Only adverse reactions considered by the investigator to be related to panitumumab together with product complaints and other safety findings were collected in this observational study.&#xD;
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Panitumumab + FOLFOX First-line</title>
          <description>Participants with metastatic colorectal cancer (mCRC) with tumor expressing wild-type RAS who received panitumumab in combination with FOLFOX as first-line treatment (FLFAS).</description>
        </group>
        <group group_id="E2">
          <title>Panitumumab + FOLFIRI Second-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as second-line treatment and received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) (SLFAS).</description>
        </group>
        <group group_id="E3">
          <title>Panitumumab + FOLFIRI First-line</title>
          <description>Participants with mCRC with tumor expressing wild-type RAS who received panitumumab in combination with FOLFIRI as first-line treatment (FLFFAS).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Inflammation of wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Eastern Cooperative Oncology Group performance status worsened</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </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="2" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Collapse circulatory</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="101" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Skin fissures</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="164"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
      <email>medinfo@amgen.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/NCT01732783
org study id: 20120100
nct id: NCT01732783
lead sponsor: 
has dmc: No
The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in
      combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog
      (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX
      or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received
      first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
observational model: Cohort
time perspective: Prospective
measure: Total Number of Panitumumab Infusions
time frame: 12 months
measure: Cumulative Dose of Panitumumab
time frame: 12 months
measure: Maximum Dose of Panitumumab
time frame: 12 months
measure: Duration of Panitumumab Exposure
time frame: 12 months
description: Duration of exposure is the time from the first to the last panitumumab infusion
measure: Mean Interval Between Panitumumab Infusions
time frame: 12 months
measure: Percentage of Participants With at Least One Panitumumab Dose Reduction
time frame: 12 months
measure: Percentage of Participants With at Least One Panitumumab Dose Delay
time frame: 12 months
measure: Reasons for Discontinuation of Panitumumab
time frame: 12 months
measure: Duration of Exposure of All Concomitant Chemotherapy
time frame: 12 months
description: Duration of exposure is the time from the first date to the last date of chemotherapy administration.
measure: Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction
time frame: 12 months
measure: Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay
time frame: 12 months
measure: Number of Participants With at Least One Hospitalization
time frame: 12 months
measure: Types of Hospital Visit
time frame: 12 months
description: Participants may have had more than one type of hospital visit.
measure: Duration of Hospital Stay
time frame: 12 months
measure: Reasons for Hospitalization
time frame: 12 months
description: Participants may have had more than one hospital visit and/or reason for a hospital visit.
measure: Percentage of Participants With an Overall Response
time frame: 12 months
description: Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).
measure: Number of Participants With Resectability
time frame: 12 months
description: Resectability denotes whether a participant became resectable during the study.
measure: Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation
time frame: 12 months
measure: Type of Post-Panitumumab Anti-cancer Treatment
time frame: 12 months
description: Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.
arm group label: Metastatic Colorectal Cancer
description: Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.
intervention type: Other
intervention name: Panitumumab + Chemotherapy
description: Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.
arm group label: Metastatic Colorectal Cancer
other name: Vectibix®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MD
role: Study Director
affiliation: Amgen
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Panitumumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 