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<docDscr>
  <citation>
    <titlStmt>
      <titl>PGRx : Graves' disease</titl>
      <IDNo>FRESH-PEF2634-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH" role="">Elodie AUBRUN</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                PGRx : Graves' disease            </titl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF2634-en            </IDNo>
      <IDNo agency="PEF">
                    2634                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF2634                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Lamiae GRIMALDI-BENSOUDA                                                                                </AuthEnty>
      <AuthEnty affiliation="L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH">
        <ExtLink title="SIREN" URI="450195979" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="L.A. SANTE EPIDEMIOLOGIE EVALUATION RECH" email="lamiae.grimaldi@aphp.fr">
                    Lamiae;GRIMALDI-BENSOUDA
                                            <ExtLink title="SIREN" URI="450195979" 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="">
                    Graves</keyword>
      <keyword vocab="" vocabURI="">
                    pharmaco-epidemiology</keyword>
      <topcClas vocab="health theme">
                        Internal medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/0d45044a-74d5-4bd7-b920-b92af3388576"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/f0844378-9f30-4873-b19b-5bff8c184a36"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D007388"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Paediatrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/bf8aaaac-ddee-41cd-bb8a-c5a63de3fcbd"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D010372"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Endocrinology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D004704"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Thyrotoxicosis with diffuse goitre                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Surveillance and assessment of the risk of Graves' disease associated with drug or vaccine use in real life situations.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2008-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General 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">Infant, Newborn (birth to 28 days)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007231"/>
                                                    </universe>
      <universe level="age" clusion="I">Infant (28 days to 2 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D007223"/>
                                                    </universe>
      <universe level="age" clusion="I">Child, Preschool (2 to 5 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002675"/>
                                                    </universe>
      <universe level="age" clusion="I">Child (6 to 12 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D002648"/>
                                                    </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 clusion="I">For the cases: patients, males and females aged 0 to 49 years, having clinical or biological signs or symptoms suggesting Graves' disease declared by the specialist, for which the first symptoms of the episode occurred less than 12 months ago.  For the controls: patients, males and females aged 0 to 49 years and older, having consulted a general practitioner.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity</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>[10000-20000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </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>
    <notes subject="observational study method">
                        Case-control study                    </notes>
    <anlyInfo>
      <respRate>- 153 cas/cases - 11125 référents/controls</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
