FRESH-PEF74132-en
Pharmaco-epidemiological observational study of the clinical beneft of Neorecormon® in cancer patients with anaemia, according to early response to treatment
FAST
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Neoplasms | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{
"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": "Inclusion criteria: - Adult patient (aged >= 18 years); - Patient receiving myelosuppressive chemotherapy (with or without radiotherapy) for solid tumor (breast, colorectal, lung, ovary), hematological malignancy (multiple myeloma, CLL, lymphoma), or autograft for hematological malignancy; - Patient without erythropoiesis-stimulating agents (ESA) treatment, neither RBC transfusion within 4 weeks before enrollment; - Patient for whom the physician had decided to initiate NeoRecormon® treatment at the inclusion visit; - Patient’s life expectancy ? 6 months according to the physician’s opinion; - Patient accepting and able to complete a French written questionnaire about his\/her professional and social activities at 4 visits, - Patient who received about the study both oral and written information and who did not object to his\/her personal data being processed. ",
"clusion_E": "None."
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2010-01-01 | 2010-12-31 |
| Standard |
|---|
| ['CDISC'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |
FRESH-PEF74132-en
| Name | Affiliation |
|---|---|
| Camille BACHOT | F. HOFFMANN-LA ROCHE AG |