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A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study

France, 2014 - 2016
Reference ID
FRESH-PEF73260-en
Producer(s)
Patrick;BLIN
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Mar 13, 2026
Last modified
Mar 13, 2026
Page views
4
  • Study Description
  • Get Microdata
  • 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-PEF73260-en

    Title

    A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study

    Abbreviation or Acronym

    SAPHARY

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data','Biological data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Gastroenterology health theme
    Extension Codes cim-11
    Keywords
    Bismuth neurological adverse event Pylera Helicobacter Pylori infection Bordeaux PharmacoEpi Service de Pharmacologie médicale

    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": "Men and women 18 years of age and older who have received a prescription for Pylera® therapy from the Investigator - Mental and legal ability to give written Informed Consent and judged by the Investigator to be capable of following the procedures outlined within the protocol ",
    "clusion_E": " Women who are pregnant or nursing - Any concern by the Investigator regarding the safe participating of the subject in the study or for any other reason the Investigator considers the subject inappropriate for participating in the study"
    }

    Producers and sponsors

    Primary investigators
    Name
    Patrick;BLIN
    Producers
    Name Role
    UNIVERSITE DE BORDEAUX sponsor
    Funding Agency/Sponsor
    Name
    ALLERGAN INDUSTRIE

    Sampling

    Sample frame

    Unit Type

    ['Through independent healthcare practitioners']

    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
    2014-01-01 2016-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}

    Study activities

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

    Quality standards

    Quality standards
    Standard
    ['MedDRA coding for neurological and non neurological adverse event (SOC and PT); ATC code']

    Data Access

    Availability Status

    {"value":"To be defined","extLink":[]}

    Notes

    The ownership of data is defined in a Master Agreement established between the Sponsor, the University of Bordeaux and ADERA (a non-profit making association).

    Contacts

    Contacts
    Name Email
    Patrick;BLIN patrick.blin@u-bordeaux.fr

    Metadata production

    DDI Document ID

    FRESH-PEF73260-en

    Producers
    Name Affiliation
    Cécile DROZ-PERROTEAU UNIVERSITE DE BORDEAUX
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