FRESH-PEF74089-en
Therapeutic management of adult or child patients with hemophilia A : A retrospective observational study - HEMONIS study
HEMONIS
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data']
Individuals
| Topic | Vocabulary |
|---|---|
| Hematology | health theme |
| Hereditary factor VIII deficiency | 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":"Child (6 to 12 years)","concept":{"vocab":"MeSH","vocabURI":"D002648"}},{"value":"Adolescent (13 to 18 years)","concept":{"vocab":"MeSH","vocabURI":"D000293"}},{"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: o Patient aged ≥ 5 years old o Patient with moderate or severe constitutional o Patient with a last visit within the last 2 years o Patient followed in the same center for 2 years previous to the last visit, or patient followed in the same center from initial diagnosis, whichever is the shortest as collected in eCRF ","clusion_E":"o Patient who has received written information and expressed his/her refusal to participate in the study, or minor patient for whom at least one parent or guardian has expressed a refusal to participate in the study as checked by programming (patients without information date) o Patient included in a clinical trial at the date of last visit as collected in eCRF"}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Other |
['Through independent healthcare practitioners']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2016-01-01 | 2018-01-01 |
| Standard |
|---|
| ['CDISC like'] |
['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 |