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<docDscr>
  <citation>
    <titlStmt>
      <titl>Cox-2 and tNSAIDs: Description of users</titl>
      <IDNo>FRESH-PEF2926-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>
                Cox-2 and tNSAIDs: Description of users            </titl>
      <altTitl>
                    CADEUS                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF2926-en            </IDNo>
      <IDNo agency="PEF">
                    2926                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF2926                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Patrick BLIN                                                                                                                            </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>
                    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">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
      <fundAg>
                                            PFIZER (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE DE BORDEAUX" email="patrick.blin@u-bordeaux.fr">
                    Patrick;BLIN
                                            <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="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="">
                    Celebrex</keyword>
      <keyword vocab="" vocabURI="">
                    NSAIDs</keyword>
      <keyword vocab="" vocabURI="">
                    traditional non-steroidal anti-inflammatory drugs</keyword>
      <keyword vocab="" vocabURI="">
                    gastroprotective drugs</keyword>
      <keyword vocab="" vocabURI="">
                    cardiovascular events</keyword>
      <keyword vocab="" vocabURI="">
                    gastrointestinal events</keyword>
      <keyword vocab="" vocabURI="">
                    health authotities (Comité Economique des Produits de Santé)</keyword>
      <keyword vocab="" vocabURI="">
                    Cyclo-oxygenase 2</keyword>
      <keyword vocab="" vocabURI="">
                    coxibs</keyword>
      <keyword vocab="" vocabURI="">
                    Vioxx</keyword>
      <keyword vocab="" vocabURI="">
                    use</keyword>
      <keyword vocab="" vocabURI="">
                    pharmacoepidemiology</keyword>
      <keyword vocab="" vocabURI="">
                    cohort</keyword>
      <keyword vocab="" vocabURI="">
                    Department of Pharmacology</keyword>
      <keyword vocab="" vocabURI="">
                    Bordeaux</keyword>
      <topcClas vocab="health theme">
                        Rheumatology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bfb0bafd-7894-45ba-84fc-ddab5fd6c537"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D012219"/>
                                                </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 objective of this study was to better understand the use of anti-inflammatory drugs, cyclo-oxygenase 2 (COX-2) or coxib (Vioxx®, Celebrex®) and traditional anti-inflammatory drugs (tNSAIDs, e.g. Aspirin, Ibuprofen) in France and to describe and assess the risks of adverse events possibly related to treatment.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2003-01-01"/>
      <collDate event="end" date="2005-01-01"/>
      <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 randomly selected from the source population using the following criteria: not dead according to the ERASME database, living in France with a valid address, with dispensation of an NSAIDs of interest during the month preceding selection, with at least one healthcare reimbursement within six months preceding the date of dispensation, for whom the contact details of the prescribing physician were available, not previously selected from the source population, not being listed under guardianship or in prison; patient agreeing to participate in the study                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Socio-demographic 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>
      <targetSampleSize>
        <sampleSizeFormula>&gt;= 20000 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <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>45 217 patients inclus - 45 217 patients included</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <confDec>- Approval of the entire study by the Advisory Committee on Research Information Processing in the Health Field and the National Commission for Data Protection and Liberties (CNIL).</confDec>
    </useStmt>
    <notes>Ownership of study data was the subject of an agreement between the University Bordeaux Segalen and pharmaceutical companies.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
