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','Biological data','Participant-reported health 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":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"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 |
| Agency name |
|---|
| Other |
['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 |