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Monitoring of chronic Immune Thrombocytopenia (ITP) treated with thrombopoietin receptor (TPO-R) agonists in France

France, 2012 - 2014
Reference ID
FRESH-PEF3133-en
Producer(s)
Christel;LECLERC-ZWIRN
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
3
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF3133-en

    Title

    Monitoring of chronic Immune Thrombocytopenia (ITP) treated with thrombopoietin receptor (TPO-R) agonists in France

    Abbreviation or Acronym

    SATURNE

    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
    Hematology health theme
    Clinical immunology health theme
    Thrombotic thrombocytopenic purpura cim-11

    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": "Young Adult (19 to 24 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
    }
    },
    {
    "value": "Adult (25 to 44 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
    }
    },
    {
    "value": "Middle Aged (45 to 64 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
    }
    },
    {
    "value": "Aged (65 to 79 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
    }
    },
    {
    "value": "Aged, 80 and over (80 years and more)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
    }
    }
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "Each participating physician is to include in a cross-sectional registry the first patients who are managed for their ITP persistent or chronic. Each physician could fill information about 15 patients maximum. Among the maximum of 15 patients included in the cross-sectional registry, each participating physician is to include in the cohort, in a consecutive manner, the first 3 to 8 patients with chronic ITP at TPO-R agonist treatment initiation in compliance with the inclusion criteria",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Christel;LECLERC-ZWIRN
    Producers
    Name Role
    GLAXOSMITHKLINE (FRANCE) sponsor
    Funding Agency/Sponsor
    Name
    GLAXOSMITHKLINE (FRANCE)

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['{"concept":{"vocabURI":"Probability.Stratified","vocab":"CESSDA"},"value":"Probability: Stratified"}']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2012-01-01 2014-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"SelfAdministeredQuestionnaire","vocab":"CESSDA"},"value":"Self-administered questionnaire"}
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    Data Access

    Availability Status

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

    Contacts

    Contacts
    Name Email
    Christel;LECLERC-ZWIRN christel.c.leclerc-zwirn@gsk.com

    Metadata production

    DDI Document ID

    FRESH-PEF3133-en

    Producers
    Name Affiliation
    Christel LECLERC-ZWIRN GLAXOSMITHKLINE (FRANCE)
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