{"title":"临床试验不良事件数据的统计分析。特别强调重大事件。","authors":"R T O'Neill","doi":"10.1177/009286158702100104","DOIUrl":null,"url":null,"abstract":"<p><p>The purpose of this paper is to describe some methods for analyzing and summarizing adverse event rates from clinical trials, emphasizing, in particular, serious adverse drug events and their time of occurrence, and the impact of differential subject exposure and pretreatment status on the estimation of rates.</p>","PeriodicalId":51023,"journal":{"name":"Drug Information Journal","volume":"21 1","pages":"9-20"},"PeriodicalIF":0.0000,"publicationDate":"1987-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1177/009286158702100104","citationCount":"37","resultStr":"{\"title\":\"Statistical analyses of adverse event data from clinical trials. Special emphasis on serious events.\",\"authors\":\"R T O'Neill\",\"doi\":\"10.1177/009286158702100104\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The purpose of this paper is to describe some methods for analyzing and summarizing adverse event rates from clinical trials, emphasizing, in particular, serious adverse drug events and their time of occurrence, and the impact of differential subject exposure and pretreatment status on the estimation of rates.</p>\",\"PeriodicalId\":51023,\"journal\":{\"name\":\"Drug Information Journal\",\"volume\":\"21 1\",\"pages\":\"9-20\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1987-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1177/009286158702100104\",\"citationCount\":\"37\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Information Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/009286158702100104\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Information Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/009286158702100104","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Statistical analyses of adverse event data from clinical trials. Special emphasis on serious events.
The purpose of this paper is to describe some methods for analyzing and summarizing adverse event rates from clinical trials, emphasizing, in particular, serious adverse drug events and their time of occurrence, and the impact of differential subject exposure and pretreatment status on the estimation of rates.
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