@Article{信息:doi 10.2196 / / medinform。6437，作者=“Luo, Jake and Eldredge, Christina and Cho, Chi C and Cisler, Ron A”，标题=“使用大临床试验数据的不同年龄组不良事件人群分析”，期刊=“JMIR Med Inform”，年=“2016”，月=“Oct”，日=“17”，卷=“4”，数=“4”，页=“e30”，关键词=“大数据分析;不良事件;临床试验数据;人口健康;临床试验安全性;背景:了解跨人群临床研究中的不良事件模式对临床试验中的患者安全和保护以及制定适当的药物治疗、程序和治疗计划都很重要。目的:本研究的目的是进行数据驱动的基于人群的分析，以估计临床试验患者和参与者按年龄划分的不良事件的发生率、多样性和关联模式。方法:对不良事件模式的两个方面进行测量:(1)每个患者年龄组的不良事件发生率;(2)不良事件的多样性，即按器官系统分类的不同类型的不良事件。对总结的临床试验数据进行统计分析。 The incident rate and diversity level in each of the age groups were compared with the lowest group (reference group) using t tests. Cohort data was obtained from ClinicalTrials.gov, and 186,339 clinical studies were analyzed; data were extracted from the 17,853 clinical trials that reported clinical outcomes. The total number of clinical trial participants was 6,808,619, and total number of participants affected by adverse events in these trials was 1,840,432. The trial participants were divided into eight different age groups to support cross-age group comparison. Results: In general, children and older patients are more susceptible to adverse events in clinical trial studies. Using the lowest incidence age group as the reference group (20-29 years), the incidence rate of the 0-9 years-old group was 31.41{\%}, approximately 1.51 times higher (P=.04) than the young adult group (20-29 years) at 20.76{\%}. The second-highest group is the 50-59 years-old group with an incidence rate of 30.09{\%}, significantly higher (P<.001) when compared with the lowest incidence in the 20-29 years-old group. The adverse event diversity also increased with increase in patient age. Clinical studies that recruited older patients (older than 40 years) were more likely to observe a diverse range of adverse events (P<.001). Adverse event diversity increased at an average rate of 77{\%} for each age group (older than 30 years) until reaching the 60-69 years-old group, which had a diversity level of 54.7 different types of adverse events per trial arm. The 70-100 years-old group showed the highest diversity level of 55.5 events per trial arm, which is approximately 3.44 times more than the 20-29 years-old group (P<.001). We also observe that adverse events display strong age-related patterns among different categories. Conclusion: The results show that there is a significant adverse event variance at the population level between different age groups in clinical trials. The data suggest that age-associated adverse events should be considered in planning, monitoring, and regulating clinical trials. ", issn="2291-9694", doi="10.2196/medinform.6437", url="http://medinform.www.mybigtv.com/2016/4/e30/", url="https://doi.org/10.2196/medinform.6437", url="http://www.ncbi.nlm.nih.gov/pubmed/27751983" }