{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T22:27:07Z","timestamp":1768861627633,"version":"3.49.0"},"reference-count":0,"publisher":"Bentham Science Publishers Ltd.","issue":"2","content-domain":{"domain":["eurekaselect.com"],"crossmark-restriction":true},"short-container-title":["CRCEP"],"published-print":{"date-parts":[[2021,8,3]]},"abstract":"<jats:sec>\n<jats:title>Background:<\/jats:title>\n<jats:p>Signal strength for any drug-event combination can be determined using\ndisproportionality analysis. Vemurafenib is a BRAF inhibitor approved by the US Food and Drug\nAdministration (FDA) in 2011 for the treatment of metastatic melanoma. This study aims to identify\nthe signal strength of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated\nwith vemurafenib using disproportionality analysis in FDA database of Adverse Event Reporting\nSystem (FAERS).<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods:<\/jats:title>\n<jats:p> Data were obtained from the public release of data in FAERS. Case\/non-case method was adopted for the analysis\nof association between vemurafenib use and DRESS. The data mining algorithm used for the analysis was Reporting Odds\nRatio (ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE&gt;1, PRR\u22652 were considered as positive\nsignal strength.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Results:<\/jats:title>\n<jats:p>A total of 7,171 reports for DRESS have been reported in the FDA database. Amongst which 125 reports were\nassociated with vemurafenib. A cumulative ROR of 17.72 (95% CI 14.83; 21.18) and PRR of 17.46 (95% CI 14.65; 20.81)\nwere observed. Combination treatment of vemurafenib with cobimetinib had higher number of reports (100) with ROR of\n103.42 (84.13- 127.14) and PRR of 94.52 (78.26- 114.15). Four deaths were reported and the non-death serious reports\nincluded hospitalization, life-threatening, disability, and other serious events with 61, 11, 2 and 39 reports respectively.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Conclusion:<\/jats:title>\n<jats:p> Positive signal strength was observed for vemurafenib associated DRESS. The signal strength was higher for\nvemurafenib in combination with cobimetinib than vemurafenib alone. Health care professionals should be cautious about\nencountering serious adverse events and should be reported to the regulatory authorities.\n<\/jats:p>\n<\/jats:sec>","DOI":"10.2174\/1574884715666200628113508","type":"journal-article","created":{"date-parts":[[2020,6,29]],"date-time":"2020-06-29T17:03:25Z","timestamp":1593450205000},"page":"168-173","update-policy":"https:\/\/doi.org\/10.2174\/bsp_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Vemurafenib Induced Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): A Disproportionality Analysis in FAERS Database"],"prefix":"10.2174","volume":"16","author":[{"given":"Reddy","family":"Neha","sequence":"first","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elsa","family":"Beulah","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bellapu","family":"Anusha","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sharma","family":"Vasista","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chacko","family":"Stephy","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1721-4553","authenticated-orcid":true,"given":"Viswam","family":"Subeesh","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Faculty of Pharmacy, M.S. Ramaiah University of Applied Sciences, Bengaluru, India"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"965","container-title":["Current Reviews in Clinical and Experimental Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/eurekaselect.com\/article\/download\/183250","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.eurekaselect.com\/183250\/article","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/eurekaselect.com\/article\/download\/183250","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T16:39:27Z","timestamp":1628613567000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.eurekaselect.com\/183250\/article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,3]]},"references-count":0,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021,8,3]]}},"alternative-id":["LiveAll1"],"URL":"https:\/\/doi.org\/10.2174\/1574884715666200628113508","relation":{},"ISSN":["2772-4328"],"issn-type":[{"value":"2772-4328","type":"print"}],"subject":[],"published":{"date-parts":[[2021,8,3]]},"assertion":[{"value":"Peer Reviewed","order":0,"name":"review_status","label":"Review Status","group":{"name":"peer_review_details","label":"Peer Review Details"}},{"value":"Single blind","order":1,"name":"review_process","label":"Review Process","group":{"name":"peer_review_details","label":"Peer Review Details"}},{"value":"Checked with iThenticate","order":0,"name":"screening_status","label":"Screening Status","group":{"name":"plagiarism_screening","label":"Plagiarism Screening"}},{"value":"2020-01-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-04-22","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-08-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}