<?xml version="1.0" encoding="UTF-8"?>
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<docDscr>
  <citation>
    <titlStmt>
      <titl>Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent</titl>
      <IDNo>FRESH-PEF2907-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE DE BORDEAUX" role="">Cécile DROZ-PERROTEAU</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent            </titl>
      <altTitl>
                    ETNA                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF2907-en            </IDNo>
      <IDNo agency="PEF">
                    2907                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF2907                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Annie FOURRIER-REGLAT                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Nicholas MOORE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE DE BORDEAUX">
        <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
        <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            UNIVERSITE DE BORDEAUX                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            F. HOFFMANN-LA ROCHE AG                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="annie.fourrier-reglat@u-bordeaux.fr">
                    Annie;FOURRIER-REGLAT
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="nicholas.moore@u-bordeaux.fr">
                    Nicholas;MOORE
                                            <ExtLink title="ROR" URI="https://ror.org/057qpr032" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="130018351" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Metastatic colorectal cancer</keyword>
      <keyword vocab="" vocabURI="">
                    first-line</keyword>
      <keyword vocab="" vocabURI="">
                    conditions of use</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacoepidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    Department of Pharmacology</keyword>
      <keyword vocab="" vocabURI="">
                    bevacizumab</keyword>
      <keyword vocab="" vocabURI="">
                    Avastin®</keyword>
      <keyword vocab="" vocabURI="">
                    tolerance</keyword>
      <keyword vocab="" vocabURI="">
                    survival</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <keyword vocab="" vocabURI="">
                    Bordeaux</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="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">The main objectives of the study were to describe the population of patients with metastatic colorectal cancer and treated in real-life with first-line bevacizumab, describe the conditions of use of this drug, evaluate the safety of treatments and effectiveness in terms of response and overall and progression free survival at 12 and 24 months follow up.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2007-01-01"/>
      <collDate event="end" date="2011-01-01"/>
      <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">Patient with metastatic colorectal cancer who initiated bevacizumab in first-line palliative treatment regardless of the associated cancer treatment between 1 January 2006 and 31 December 2007 (whether or not the treatment is continued); Interval between adjuvant chemotherapy for primary cancer and the initiation of bevacizumab ≥6 months; Absence of chemotherapy for metastases before initiation of bevacizumab; Patient had not previously treated with bevacizumab, including during a clinical trial or Temporary Authorisation of Use; Patient with a prescribing physician or their head of department who agreed to participate in the study; Patient not participating in a clinical trial (Huriet-Sérusclat), unless it has a standard treatment (control arm) in an open-label Phase III study (bevacizumab known); Patient not objecting to the data collection.                    </universe>
      <dataKind>Clinical data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Medical-administrative database (patients</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>health insurance/mutual insurance) Disease and death registry</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>411</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <notes>Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen, the Bordeaux University Hospital and the pharmaceutical company.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
