FRESH-PEF73260-en
A Safety and Pharmacokinetic study in Real-life practice of Pylera® in France: The SAPHARY study
SAPHARY
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Gastroenterology | health theme |
| Extension Codes | cim-11 |
{
"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"
}
| Name |
|---|
| Patrick;BLIN |
| Name | Role |
|---|---|
| UNIVERSITE DE BORDEAUX | sponsor |
| Name |
|---|
| ALLERGAN INDUSTRIE |
['Through independent healthcare practitioners']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2014-01-01 | 2016-01-01 |
| Standard |
|---|
| ['MedDRA coding for neurological and non neurological adverse event (SOC and PT); ATC code'] |
{"value":"To be defined","extLink":[]}
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).
| Name | |
|---|---|
| Patrick;BLIN | patrick.blin@u-bordeaux.fr |
FRESH-PEF73260-en
| Name | Affiliation |
|---|---|
| Cécile DROZ-PERROTEAU | UNIVERSITE DE BORDEAUX |