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        <titl xml:lang="FR">Etude longitudinale sur l'utilisation de la drotrécogine alpha activée (Xigris®) en France</titl>
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        <altTitl xml:lang="FR">B009</altTitl>
        <altTitl xml:lang="EN">B009</altTitl>
        <parTitl xml:lang="EN">Follow-up study of patients treated with drotrecogin alfa (activated) (Xigris®) in France</parTitl>
        <IDNo>PEF75</IDNo>
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        <AuthEnty affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France</AuthEnty>
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        <producer abbr="PEF-HD" affiliation="ITMO Santé Publique, Aviesan">Portail Épidémiologie-France | Health Databases</producer>
        <copyright>Portail Épidémiologie-France 2026</copyright>
        <prodDate date="2026-04-03">03/04/2026</prodDate>
        <prodPlac>https://epidemiologie-france.aviesan.fr/</prodPlac>
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        <distrbtr>Portail Épidémiologie-France</distrbtr>
        <contact email="portail-epidemiologie@inserm.fr">Portail Epidemiologie-France</contact>
        <depositr>Béatrice Augendre-Ferrante</depositr>
        <depDate xml:lang="FR">14/12/2010</depDate>
        <depDate xml:lang="EN">19/06/2012</depDate>
        <distDate>01/01/2019</distDate>
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        <verResp>Béatrice Augendre-Ferrante</verResp>
        <notes/>
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      <biblCit/>
      <holdings xml:lang="FR" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/en/content/view/full/84544">B009 - Etude longitudinale sur l'utilisation de la drotrécogine alpha activée (Xigris®) en France</holdings>
      <holdings xml:lang="EN" location="Portail Epidemiologie-France" URI="http://admin-epid-prod2.inserm.fr/en/content/view/full/84545">B009 - Follow-up study of patients treated with drotrecogin alfa (activated) (Xigris®) in France</holdings>
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    <citation>
      <titlStmt>
        <titl xml:lang="FR">Etude longitudinale sur l'utilisation de la drotrécogine alpha activée (Xigris®) en France</titl>
        <subTitl/>
        <altTitl xml:lang="FR">B009</altTitl>
        <altTitl xml:lang="EN">B009</altTitl>
        <parTitl xml:lang="EN">Follow-up study of patients treated with drotrecogin alfa (activated) (Xigris®) in France</parTitl>
        <IDNo/>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation=""> Laboratoire</AuthEnty>
      </rspStmt>
      <prodStmt>
        <producer role="Private">Eli Lilly</producer>
        <copyright/>
        <prodDate/>
        <prodPlac>Eli Lilly France -  - </prodPlac>
        <software/>
        <fundAg xml:lang="FR" role="Privé">Eli Lilly and Company</fundAg>
        <fundAg xml:lang="EN" role="Private">Eli Lilly and Company</fundAg>
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      <distStmt>
        <distrbtr/>
        <contact affiliation="" email="Fr_mail_pharmacoepi@lilly.com"> Laboratoire</contact>
        <depositr>Béatrice Augendre-Ferrante</depositr>
        <depDate xml:lang="FR">14/12/2010</depDate>
        <depDate xml:lang="EN">19/06/2012</depDate>
        <distDate xml:lang="FR">01/01/2019</distDate>
        <distDate xml:lang="EN">01/01/2019</distDate>
      </distStmt>
      <serStmt>
        <serName/>
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        <version xml:lang="FR" date="01/01/2019">1</version>
        <version xml:lang="EN" date="01/01/2019">1</version>
        <verResp>Béatrice Augendre-Ferrante</verResp>
        <notes/>
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    <studyAuthorization>
      <authorizingAgency>CNIL</authorizingAgency>
      <authorizationStatement xml:lang="FR">CNIL N°908282</authorizationStatement>
      <authorizationStatement xml:lang="EN">CNIL N°908282</authorizationStatement>
    </studyAuthorization>
    <stdyInfo>
      <studyBudget/>
      <subject>
        <keyword xml:lang="FR">Sepsis sévère</keyword>
        <keyword xml:lang="FR">drotrécogine alpha (activée)</keyword>
        <keyword xml:lang="FR">conditions d'utilisation</keyword>
        <keyword xml:lang="FR">survie</keyword>
        <keyword xml:lang="EN">Severe sepsis</keyword>
        <keyword xml:lang="EN">drotrecogin alpha (activated)</keyword>
        <keyword xml:lang="EN">survival</keyword>
        <keyword xml:lang="EN">conditions of use</keyword>
        <topcClas xml:lang="FR">Maladies infectieuses</topcClas>
        <topcClas xml:lang="EN">Infectious diseases</topcClas>
        <topcClas xml:lang="FR">Produits de santé</topcClas>
        <topcClas xml:lang="EN"/>
      </subject>
      <abstract xml:lang="FR">Objectif de la base de données : Objectif principal : évaluer la mortalité à 1 mois (28 jours et 31 jours) des patients atteints de sepsis sévère et traités par drotrécogine alfa (activée) en réanimation et décrire les causes de décès.
Objectifs sécondaires : caractéristiques des patients et conditions de l’utilisation.</abstract>
      <abstract xml:lang="EN">Database objective : Primary objective: evaluate 1-month mortality (at 28 days and 31 days) of patients treated with drotrecogin alpha (activated) in intensive care forsevere sepsis and describe causes of death.
Secondary objectives: characteristics of patients and conditions of use.</abstract>
      <sumDscr>
        <timePrd/>
        <collDate event="start">2008</collDate>
        <collDate event="end">2009</collDate>
        <collDate xml:lang="FR">Collecte des données terminée</collDate>
        <collDate xml:lang="EN">Data collection completed</collDate>
        <nation>France</nation>
        <geogCover xml:lang="FR">National</geogCover>
        <geogCover xml:lang="EN">National</geogCover>
        <geogUnit>National</geogUnit>
        <anlyUnit xml:lang="fr">individuel
                </anlyUnit>
        <anlyUnit xml:lang="en">individuals
                </anlyUnit>
        <universe xml:lang="FR" clusion="I">Tous les patients adultes traités par drotrécogine alfa (activée) en France dans le cadre de l’utilisation usuelle dans des services de réanimation.</universe>
        <universe xml:lang="EN" clusion="I">All adult patients treated with drotrecogin alpha (activated) in France in the course of routine care in intensive care services.</universe>
        <universe xml:lang="FR">Nombre d'individus : 1049</universe>
        <universe xml:lang="EN">Number of individuals: 1049</universe>
        <universe xml:lang="FR">Recrutement via une sélection de services ou établissements de santé</universe>
        <universe xml:lang="EN">Recruiting through a selection of health institutions and services</universe>
        <universe xml:lang="FR">sur la base Prise de produit(s) de santé</universe>
        <universe xml:lang="EN">based on Medication(s) taken</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (19 à 24 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (25 à 44 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Adulte (45 à 64 ans)</universe>
        <universe xml:lang="FR" level="Tranche d'âge">Personnes âgées (65 à 79 ans)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (19 to 24 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (25 to 44 years)</universe>
        <universe xml:lang="EN" level="Age range">Adulthood (45 to 64 years)</universe>
        <universe xml:lang="EN" level="Age range">Elderly (65 to 79 years)</universe>
        <universe xml:lang="FR" level="Type de population">Sujets malades</universe>
        <universe xml:lang="EN" level="Population type">Sick population</universe>
        <universe xml:lang="FR" level="Sexe">Masculin</universe>
        <universe xml:lang="FR" level="Sexe">Féminin</universe>
        <universe xml:lang="EN" level="Sex">Male</universe>
        <universe xml:lang="EN" level="Sex">Female</universe>
        <dataKind xml:lang="FR">Bases de données issues d’enquêtes</dataKind>
        <dataKind xml:lang="EN">Study databases</dataKind>
        <dataKind xml:lang="FR">Etudes longitudinales (hors cohortes)</dataKind>
        <dataKind xml:lang="EN">Longitudinal study (except cohorts)</dataKind>
        <dataKind xml:lang="FR">Données cliniques : </dataKind>
        <dataKind xml:lang="FR">Données biologiques : hématologie, biochimie</dataKind>
        <dataKind xml:lang="EN">Clinical data: </dataKind>
        <dataKind xml:lang="EN">Biological data: hematology, biochemistry</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/morbidité</dataKind>
        <dataKind xml:lang="FR">Evénements de santé/mortalité</dataKind>
        <dataKind xml:lang="EN">Health event/morbidity</dataKind>
        <dataKind xml:lang="EN">Health event/mortality</dataKind>
        <dataKind xml:lang="FR"/>
        <dataKind xml:lang="EN"/>
      </sumDscr>
      <qualityStatement>
        <standardsCompliance>
          <standard>
            <standardName/>
            <producer/>
          </standard>
          <complianceDescription/>
        </standardsCompliance>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
        <otherQualityStatement xml:lang="FR"/>
        <otherQualityStatement xml:lang="EN"/>
      </qualityStatement>
      <notes/>
      <exPostEvaluation>
        <evaluator/>
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        <outcomes/>
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        <description/>
        <participant/>
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          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
          <dataSrc/>
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          <srcChar/>
          <srcDocu/>
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        <outcome/>
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      <dataColl>
        <timeMeth method="http://www.ddialliance.org/Specification/DDI-CV/TimeMethod_1.2_Genericode1.0_DDI-CVProfile1.0.xml">Time Series</timeMeth>
        <dataCollector affiliation=""> Laboratoire</dataCollector>
        <collectorTraining/>
        <frequenc xml:lang="FR">31 jours</frequenc>
        <frequenc xml:lang="EN"/>
        <sampProc xml:lang="FR">Tous les services de réanimation des hôpitaux français ayant traité des patients par drotrécogine alfa (activée)dans la période de l'étude étaient éligibles.</sampProc>
        <sampProc xml:lang="EN">All intensive care services in French hospitals which treated patients with drotrecogin alpha (activated) during the study period were eligible.</sampProc>
        <deviat/>
        <collMode xml:lang="FR">Cahier de recueil des données</collMode>
        <collMode xml:lang="EN">Study data collection form</collMode>
        <collMode xml:lang="FR">Dossier cliniqueExamen médical : </collMode>
        <collMode xml:lang="EN">Direct physical measuresMedical registration: </collMode>
        <collMode xml:lang="FR">hématologie, biochimie</collMode>
        <collMode xml:lang="EN">hematology, biochemistry</collMode>
        <collMode xml:lang="FR"/>
        <collMode xml:lang="EN"/>
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        <txt/>
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        <origArch/>
        <avlStatus xml:lang="FR">Rapports et publications</avlStatus>
        <avlStatus xml:lang="EN">Reports and publications</avlStatus>
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        <complete/>
        <fileQnty/>
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        <restrctn xml:lang="FR">Rapports et publications</restrctn>
        <restrctn xml:lang="EN">Reports and publications</restrctn>
        <contact/>
        <citReq/>
        <deposReq/>
        <conditions xml:lang="FR">Rapports et publications</conditions>
        <conditions xml:lang="EN">Reports and publications</conditions>
        <disclaimer/>
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