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Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label/unlicensed prescriptions

France, 2013 - 2016
Reference ID
FRESH-PEF39007-en
Producer(s)
Behrouz;KASSAI-KOUPAI
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
37
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts

    • Identification

    Survey ID number

    FRESH-PEF39007-en
    Title

    Longitudinal study in patients aged 0 to 15 years hospitalised for at least 3 days after receiving at least one drug: risk of adverse drug reactions associated with off-label/unlicensed prescriptions
    Abbreviation or Acronym

    EREMI
    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Biological data','Socio-demographic data','Participant-reported health data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Paediatrics health theme
    External causes of morbidity or mortality cim-11
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    drug ADEs Adverse drug episodes adverse effect market authorisation prescription Hospitalisation MA child adolescent

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Infant, Newborn (birth to 28 days)","concept":{"vocab":"MeSH","vocabURI":"D007231"}},{"value":"Infant (28 days to 2 years)","concept":{"vocab":"MeSH","vocabURI":"D007223"}},{"value":"Child, Preschool (2 to 5 years)","concept":{"vocab":"MeSH","vocabURI":"D002675"}},{"value":"Child (6 to 12 years)","concept":{"vocab":"MeSH","vocabURI":"D002648"}},{"value":"Adolescent (13 to 18 years)","concept":{"vocab":"MeSH","vocabURI":"D000293"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"Children from 0 to 15 years old [0 ; 15[ (including term and preterm newborn infants). Hospitalised for at least 3 days. Receiving at least one medication","clusion_E":""}

    Producers and sponsors

    Primary investigators
    Name
    Behrouz;KASSAI-KOUPAI
    Producers
    Name Role
    HOSPICES CIVILS DE LYON (HCL) sponsor
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP) sponsor
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
    Other Identifications/Acknowledgments
    Name
    CIC Pédiatrique - Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon (HCL) / CIC pédiatrique - Hôpital Robert Debré, Assistance publique – Hôpitaux de Paris (AP-HP)

    Study authorization

    Agency
    Agency name
    CNIL

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)','Population database for statistical purposes']
    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2013-01-01 2016-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services

    Quality standards

    Other quality statement

    ['Methodology: HCL Paediatric Clinical Investigation Centre; Biostatistics: Biostatistics department of HCL/UMR CNRS 5558; Management of the database: ClinInfo, Lyon']

    Data Access

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Contacts

    Contacts
    Name Email
    Behrouz;KASSAI-KOUPAI behrouz.kassai-koupai@chu-lyon.fr
    Kim An;NGUYEN kim-an.nguyen@chu-lyon.fr
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