{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T18:00:55Z","timestamp":1792173655409,"version":"4.4.0"},"reference-count":13,"publisher":"Wiley","issue":"24","license":[{"start":{"date-parts":[[2006,10,12]],"date-time":"2006-10-12T00:00:00Z","timestamp":1160611200000},"content-version":"vor","delay-in-days":4669,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[1993,12,30]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>When monitoring spontaneous reports of adverse reactions to registered drugs, it is important to detect any change in the number of reported adverse reactions in the course of time. Sales adjusted adverse drug reaction rates are usually compared in order to be able to take drug exposure into account. Here we review the so\u2010called arithmetic and some statistical procedures which could form the basis for an alert system. The advantages and disadvantages of each of these methods are discussed. The importance of data requirements and the problems which arise when using an alert system are pointed out and then clarified with the help of the example of diphtheria\/tetanus vaccine.<\/jats:p>","DOI":"10.1002\/sim.4780122414","type":"journal-article","created":{"date-parts":[[2007,4,27]],"date-time":"2007-04-27T22:46:33Z","timestamp":1177713993000},"page":"2383-2393","source":"Crossref","is-referenced-by-count":29,"title":["Alert systems for post\u2010marketing surveillance of adverse drug reactions"],"prefix":"10.1002","volume":"12","author":[{"given":"Michaela","family":"Praus","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fritz","family":"Schindel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reinhard","family":"Fescharek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Schwarz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2006,10,12]]},"reference":[{"key":"e_1_2_1_2_2","volume-title":"Statistical Tables for the Design of Clinical Trials","author":"Machin D.","year":"1987"},{"key":"e_1_2_1_3_2","doi-asserted-by":"crossref","unstructured":"Lewis J. A.\u2018Post\u2010marketing surveillance: how many patients?\u2019 TIPS 93\u201394(April1981).","DOI":"10.1016\/0165-6147(81)90275-3"},{"key":"e_1_2_1_4_2","doi-asserted-by":"crossref","first-page":"1023","DOI":"10.1002\/sim.4780071004","article-title":"A statistical methodology for postmarketing surveillance of adverse drug reaction reports","volume":"7","author":"Norwood P. K.","journal-title":"Statistics in Medicine"},{"key":"e_1_2_1_5_2","unstructured":"Drug Information Association. \u201cPostmarketing Reporting of Adverse Reactions\u201d FDA Division of Epidemiology and Surveillance Workshop Rockville Maryland 16th May1988."},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/41.1-2.100"},{"key":"e_1_2_1_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780030306"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780080306"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.2307\/2985287"},{"key":"e_1_2_1_10_2","volume-title":"Statistical Process Control","author":"Oakland J. 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M.","year":"1986","journal-title":"The American Journal of Medicine"},{"key":"e_1_2_1_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780010208"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fsim.4780122414","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.4780122414","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,25]],"date-time":"2023-10-25T21:20:54Z","timestamp":1698268854000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.4780122414"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1993,12,30]]},"references-count":13,"journal-issue":{"issue":"24","published-print":{"date-parts":[[1993,12,30]]}},"alternative-id":["10.1002\/sim.4780122414"],"URL":"https:\/\/doi.org\/10.1002\/sim.4780122414","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[1993,12,30]]}}}