Geographical variation in adverse event reporting rates in clinical trials
Geographical variation in adverse event reporting rates in clinical trials
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DOI：
10.1002/(sici)1099-1557(199710)6:3
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发表时间：
1997-10-01
影响因子：
2.6
通讯作者：
Wallander, MA
中科院分区：
文献类型：
--
作者：
Joelson, S;Joelson, IB;Wallander, MA
来自13个国家进行的127项胃肠道临床试验的13，698例患者被纳入分析。报告的所有不良事件均纳入评价中。计算每个国家的一般不良事件报告率、报告的不良事件平均数量、严重不良事件报告率和报告的严重不良事件平均数量。此外，还研究了每个国家报告的不良事件模式。一般不良事件报告率在17%-68%之间变化，平均值为47%，严重不良事件报告率在1%-20%之间变化，平均值为8%。报告不良事件的患者报告的不良事件的平均数量在1.5 - 2.7之间变化，平均值为2.1，报告严重不良事件的患者报告的严重不良事件的平均数量在1.1 - 1.7之间变化，平均值为1.4。除了这些差异外，患者/研究者倾向于强调不同国家的不同类型的不良事件。(C)John Wiley & Sons，Ltd.
A group of 13,698 patients from 127 gastro-intestinal clinical trials, conducted in 13 countries was included in the analyses. All adverse events reported were included in the evaluation. The general adverse event reporting rate, the mean number of adverse events reported, the serious adverse event reporting rate and the mean number of serious adverse events reported were calculated for each country. In addition, the pattern of adverse events reported in each country was studied. The general adverse event reporting rate varied between 17% and 68% with a mean of 47% and the serious adverse event reporting rate varied between 1% and 20% with a mean of 8%. The mean number of adverse events, reported by patients reporting adverse events, varied between 1.5 and 2.7 with a mean of 2.1 and the mean number of serious adverse events, reported by patients reporting serious adverse events, varied between 1.1 and 1.7 with a mean of 1.4. In addition to these differences, patients/investigators had a tendency to put emphasis on different kinds of adverse events in different countries. (C) 1997 John Wiley & Sons, Ltd.