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<docDscr>
  <citation>
    <titlStmt>
      <titl>Velcade: study of real-life use</titl>
      <IDNo>FRESH-PEF3195-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>
                Velcade: study of real-life use            </titl>
      <altTitl>
                    VESUVE (beta)                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3195-en            </IDNo>
      <IDNo agency="PEF">
                    3195                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3195                </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">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE DE BORDEAUX                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            JANSSEN CILAG (JANSSEN - JOHNSON &amp;amp; JOHNSON - JOHNSON &amp;amp; JOHNSON INNOVATIVE MEDICINE)                    
                                    </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="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    Multiple myeloma</keyword>
      <keyword vocab="" vocabURI="">
                    Velcade®</keyword>
      <keyword vocab="" vocabURI="">
                    Bortezomib</keyword>
      <keyword vocab="" vocabURI="">
                    survival</keyword>
      <keyword vocab="" vocabURI="">
                    conditions of 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">
                        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">
                        Hematology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/9239f328-78c9-40a5-a0b9-8e66fd9b6245"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006402"/>
                                                </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 objectives are to evaluate the response and survival of patients treated by Velcade®, to describe the population of patients initiating treatment with Velcade® (socio-demographic data, previous treatments, indication), and describe the conditions of use Velcade® (dose, number and frequency of treatment cycles)</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2004-01-01"/>
      <collDate event="end" date="2006-01-01"/>
      <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">Patients initiating Bortezomib treatment between 1 May 2004 and April 30 2006 (whether or not treatment is continued); Patient unexposed to bortezomib, including during a clinical trial or temporary use authorization; Patient followed by a hospital physician having agreed to participate in the study; Patient not participating in a clinical trial; Patient not objecting to 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>Through independent healthcare practitioners Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[500-1000[ 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>1310 patients identified by hospital pharmacists, including 924 patients for whom their physician agreed to participate in the study, and 793 patients were eligible for follow up.</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 and the pharmaceutical company.</notes>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
