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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
Metadata
DDI/XML JSON
Created on
Dec 18, 2025
Last modified
Dec 18, 2025
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  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production

    • 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','Participant-reported health data','Biological data','Socio-demographic 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": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
    }
    },
    {
    "value": "Female",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
    }
    }
    ],
    "level_age_clusion_I": [
    {
    "value": "Infant, Newborn (birth to 28 days)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D007231"
    }
    },
    {
    "value": "Infant (28 days to 2 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D007223"
    }
    },
    {
    "value": "Child, Preschool (2 to 5 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D002675"
    }
    },
    {
    "value": "Child (6 to 12 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D002648"
    }
    }
    ],
    "level_type_clusion_I": "Patients population",
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Producers
    Name
    ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)
    HOSPICES CIVILS DE LYON
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)

    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

    Metadata production

    DDI Document ID

    FRESH-PEF39007-en
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