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Disproportionality analyses were carried out by calculating reporting odds ratios (RORs) with 95% confidence interval (CI), accounting for major confounders, including notoriety and competition biases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>ILD reports (<jats:italic>N<\/jats:italic>\u00a0=\u00a0161) represented 2.1% and 0.3% of all reports for abemaciclib and palbocilcib\/ribociclib, respectively, with negligible proportion of concomitant pneumotoxic drugs. Increased reporting was found for CDK4\/6 inhibitors when compared to other drugs (ROR\u2009=\u00a01.50; 95%CI\u2009=\u00a01.28\u20131.74), and abemaciclib vs other anticancer agents (4.70; 3.62\u20135.98). Sensitivity analyses confirmed a strong and consistent disproportionality for abemaciclib. Higher-than-expected reporting emerged for palbociclib (1.38; 1.07\u20131.77) and ribociclib (2.39; 1.34\u20133.92) only when removing Japan reports. ILD occurred at recommended daily doses, with median latency ranging from 50 (abemaciclib) to 253 (ribociclib) days. Causality was <jats:italic>highly probable<\/jats:italic> in 55% of abemaciclib cases, <jats:italic>probable<\/jats:italic> in 68% of palbociclib cases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Increased reporting of ILD with CDK4\/6 inhibitors calls for further comparative population-based studies to characterize and quantify the actual risk, taking into account drug- and patient-related risk factors. These findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals through FAERS and other real-world data, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of CDK4\/6 inhibitors when diagnosing a lung injury.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10549-020-06001-w","type":"journal-article","created":{"date-parts":[[2020,11,5]],"date-time":"2020-11-05T03:02:31Z","timestamp":1604545351000},"page":"219-227","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":98,"title":["Cyclin-dependent kinase 4\/6 inhibitors and interstitial lung disease in the FDA adverse event reporting system: a pharmacovigilance assessment"],"prefix":"10.1007","volume":"186","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0487-7996","authenticated-orcid":false,"given":"Emanuel","family":"Raschi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Fusaroli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Ardizzoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Poluzzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"De Ponti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,5]]},"reference":[{"key":"6001_CR1","doi-asserted-by":"publisher","first-page":"817","DOI":"10.1016\/S0140-6736(20)30165-3","volume":"395","author":"LM Spring","year":"2020","unstructured":"Spring LM, Wander SA, Andre F, Moy B, Turner NC, Bardia A (2020) Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future. 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AA reports grants and personal fees from BMS, personal fees from MSD, personal fees from Eli-Lilly, personal fees from Boehringer, personal fees from Pfizer, and grants from Celgene, outside the submitted work. Other authors declare no potential conflict of interest relevant to the content of the manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This article does not contain any studies with human participants performed by any of the authors. This study is based on anonymous data that can be downloaded from a publicly available source. Therefore, no ethical approval is required.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"This study is based on anonymous data that can be downloaded from a publicly available source. Therefore, no informed consent is required.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}