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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cohort of patients with metastatic colorectal cancer initiating a chemotherapy in combination with Avastin®</titl>
      <IDNo>FRESH-PEF74088-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="F. HOFFMANN-LA ROCHE AG" role="">Camille BACHOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Cohort of patients with metastatic colorectal cancer initiating a chemotherapy in combination with Avastin®            </titl>
      <altTitl>
                    CONCERT                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF74088-en            </IDNo>
      <IDNo agency="PEF">
                    74088                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF74088                </IDNo>
      <IDNo agency="NCT">
                    NCT02612077                </IDNo>
    </titlStmt>
    <rspStmt>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="F. HOFFMANN-LA ROCHE AG" email="data_sharing.france@roche.com">
                    ;Medical data center
                                            <ExtLink title="ROR" URI="https://ror.org/01mqmer16" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="775752140" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    bevacizumab</keyword>
      <topcClas vocab="health theme">
                        Oncology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D008495"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Gastroenterology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/a3898340-a42d-4f5e-a822-1de204a9a867"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005762"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Primary Objective: To assess in real life the Progression-Free Survival at a maximum of 36 months follow-up, in patients suffering from metastatic colorectal cancer and initiating a treatment with Avastin® combined with chemotherapy. Secondary Objectives: - To describe characteristics of patients treated with Avastin® - To describe the use of Avastin® over the study period - To assess the overall survival of patients treated with Avastin® - To describe the Avastin® safety profile (serious adverse events and/or unexpected related to Avastin®, and/or adverse events of special interest) - To describe the quality of life of patients treated with Avastin®. Exploratory Objective: A search for the prognostic factors of PFS and OS was performed using a Cox model in patients treated with 1st line of chemotherapy (overall and in the subgroup of patients with synchronous metastases). These factors were determined from the characteristics of patients at inclusion.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <collDate event="end" date="2012-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Inclusion criteria:  - Adult patient (aged &gt;= 18 years) - Patient suffering from metastatic colic or rectal carcinoma for which the physician decided to start a treatment with Avastin® combined with chemotherapy, at the inclusion time - Patient who received about the study both oral and written information and who did not object to his/her personal data being processed                     </universe>
      <universe clusion="E">Participation in a clinical trial designed to assess a cytotoxic anticancer treatment and/or an innovative therapy                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
    <qualityStatement>
      <standardsCompliance>
        <standard>
          <standardName>CDISC like</standardName>
        </standard>
      </standardsCompliance>
      <otherQualityStatement>GCP/GVP</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>765</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
