Analysis of completeness of information for trial outcomes in CSRs versus publicly available sources, i.e., registry reports and/or journal publications.
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Sample: all trials with both a CSR and a registry report and/or journal publication, n = 86).aTotal number of outcomes with complete information/total number of respective outcomes in sample.bCSRs submitted to regulatory authorities.cReports posted in trial results registries.dAEs of special interest in the given indication.
样本:同时具备临床试验报告(CSR,Clinical Study Report)、注册报告及/或期刊发表文献的全部试验,样本量n=86。 a. 样本中具备完整信息的结局指标数/样本中对应结局指标的总数量; b. 提交至监管机构的临床试验报告; c. 发布于试验结果注册库的报告; d. 对应适应证中的特定关注不良事件(AEs,Adverse Events)。
创建时间:
2015-12-02



