Analysis of Drug Safety Data From Clinical Trials

被引:0
作者
Andrzej Czarnecki
Katarzyna Zalewska
机构
[1] Central Register of Clinical Trials,Drug Institute
来源
Drug information journal : DIJ / Drug Information Association | 2002年 / 36卷 / 1期
关键词
Adverse events; Clinical trials; Number of withdrawals and deaths;
D O I
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学科分类号
摘要
An analysis of combined safety data from cardiology, pulmonology, and bioequivalence studies collected at the Central Register of Clinical Trials in Poland was conducted. The number of serious adverse events, adverse events, and patient withdrawals is lower in combined data from trials than in individual published studies. In some acute and severe conditions, more adverse events are reported in placebo-treated patients than in the treatment arm.
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页码:157 / 162
页数:5
相关论文
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