{"study_desc":{"title_statement":{"idno":"FRESH-PEF96-en","IDno":{"metadata_no":[{"agency":"PEF","code":"96"},{"agency":"FReSH","code":"FRESH-PEF96"}]},"title":"MELISSE","alternate_title":""},"study_authorization":{"agency":[{"name":"CNIL"},{"name":"CPP"}]},"authoring_entity":[{"name":"Anne;LAMBLIN","firstname":"Anne","lastname":"LAMBLIN","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05","role":"organisation id"},{"title":"SIREN","uri":"572208122","role":"organisation id"},{"uri":"0009-0001-8771-2478","role":"pi id","title":"ORCID"},{"uri":"076298566","role":"pi id","title":"IdRef"}],"email":"anne.lamblin@leo-pharma.com","affiliationName":"LABORATOIRES LEO (LEO PHARMA)","PILabo":"LEO Pharma \/ LEO Pharma France","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"LABORATOIRES LEO (LEO PHARMA)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02wvemr05","role":"sponsor id"},{"title":"SIREN","uri":"572208122","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]}]},"distribution_statement":{"contact":[{"name":"Anne;LAMBLIN","lastname":"LAMBLIN","firstname":"Anne","type":"contact","email":"anne.lamblin@leo-pharma.com","affiliationName":"LABORATOIRES LEO (LEO PHARMA)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02wvemr05","role":"organisation id","title":"ROR"},{"uri":"572208122","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prophylaxis"},{"keyword":"thalidomide"},{"keyword":"lenalidomide"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Describe the prophylactic treatment of phlebitis in patients suffering from multiple myeloma and receiving thalidomide or lenalidomide treatment: - Describe the proportion of patients under prophylactic treatment for phlebitis; - Define the importance of low-molecular-weight heparins (LMWH), vitamin K antagonists (VKA) and aspirin, as well as the arrangements for their use in preventing phlebitis. Describe, over a period of 4 and then 8 months, the occurrence of thromboembolic and hemorrhagic events in patients with multiple myeloma who are under thalidomide or lenalidomide treatment, depending on the thromboprophylactic strategy set up upon inclusion","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2011-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"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 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