{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,24]],"date-time":"2025-12-24T12:16:15Z","timestamp":1766578575714},"reference-count":9,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2018,3,21]],"date-time":"2018-03-21T00:00:00Z","timestamp":1521590400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/academic.oup.com\/journals\/pages\/about_us\/legal\/notices"}],"funder":[{"name":"AstraZeneca clinical trial","award":["NCT01443845"],"award-info":[{"award-number":["NCT01443845"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,8,1]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging.<\/jats:p><\/jats:sec>Methods<\/jats:title>We introduce a new means of visualizing the adverse event data across an entire clinical trial.<\/jats:p><\/jats:sec>Results<\/jats:title>The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jamia\/ocy016","type":"journal-article","created":{"date-parts":[[2018,2,8]],"date-time":"2018-02-08T20:11:09Z","timestamp":1518120669000},"page":"1069-1073","source":"Crossref","is-referenced-by-count":12,"title":["The Tendril Plot\u2014a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials"],"prefix":"10.1093","volume":"25","author":[{"given":"Martin","family":"Karpefors","sequence":"first","affiliation":[{"name":"Advanced Analytics Centre, AstraZeneca R&D, Gothenburg, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Weatherall","sequence":"additional","affiliation":[{"name":"Advanced Analytics Centre, AstraZeneca R&D, Macclesfield, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2018,3,21]]},"reference":[{"key":"2020110612224797400_ocy016-B1","volume-title":"Notabilia - Visualizing Deletion Discussions on Wikipedia","author":"Stefaner","year":"2010"},{"key":"2020110612224797400_ocy016-B2","doi-asserted-by":"crossref","first-page":"430","DOI":"10.1177\/1740774509344101","article-title":"Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team","volume":"6","author":"Crowe","year":"2009","journal-title":"Clin Trials"},{"key":"2020110612224797400_ocy016-B3","doi-asserted-by":"crossref","first-page":"20","DOI":"10.1002\/pst.254","article-title":"Graphical approaches to the analysis of safety data from clinical trials","volume":"7","author":"Amit","year":"2008","journal-title":"Pharm Stat"},{"key":"2020110612224797400_ocy016-B4","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1177\/1740774513485311","article-title":"Summarizing the incidence of adverse events using volcano plots and time intervals","volume":"10","author":"Zink","year":"2013","journal-title":"Clin Trials"},{"key":"2020110612224797400_ocy016-B5","doi-asserted-by":"crossref","first-page":"559","DOI":"10.1164\/rccm.201607-1349OC","article-title":"Effect of roflumilast and inhaled corticosteroid\/long-acting b2-agonist on chronic obstructive pulmonary disease exacerbations (RE2SPOND) - a randomized clinical trial","volume":"194","author":"Martinez","year":"2016","journal-title":"Am J Respir Crit Care Med"},{"key":"2020110612224797400_ocy016-B6","doi-asserted-by":"crossref","first-page":"685","DOI":"10.1016\/S0140-6736(09)61255-1","article-title":"Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials","volume":"374","author":"Calverley","year":"2009","journal-title":"Lancet"},{"key":"2020110612224797400_ocy016-B7","volume-title":"R: A Language and Environment for Statistical Computing","author":"R Core Team","year":"2015"},{"key":"2020110612224797400_ocy016-B8"},{"key":"2020110612224797400_ocy016-B9","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/j.2517-6161.1995.tb02031.x","article-title":"Controlling the false discovery rate: a practical and powerful approach to multiple testing","volume":"57","author":"Benjamini","year":"1995","journal-title":"J R Stat Soc B"}],"container-title":["Journal of the American Medical Informatics Association"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/jamia\/article-pdf\/25\/8\/1069\/34150801\/ocy016.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"http:\/\/academic.oup.com\/jamia\/article-pdf\/25\/8\/1069\/34150801\/ocy016.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,1]],"date-time":"2024-07-01T02:26:29Z","timestamp":1719800789000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jamia\/article\/25\/8\/1069\/4951737"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,3,21]]},"references-count":9,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2018,3,21]]},"published-print":{"date-parts":[[2018,8,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jamia\/ocy016","relation":{},"ISSN":["1067-5027","1527-974X"],"issn-type":[{"value":"1067-5027","type":"print"},{"value":"1527-974X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2018,8]]},"published":{"date-parts":[[2018,3,21]]}}}