TY -非盟的罗,杰克AU -·克里斯蒂娜AU - Cho,气C盟——Cisler罗恩PY - 2016 DA - 2016/10/17 TI -人口分析不良事件在不同年龄组使用大型临床试验数据乔-地中海JMIR通知SP - e30六世- 4 - 4 KW -大数据分析KW -不良事件KW -临床试验数据KW -人口健康KW -临床试验安全KW -数据处理和集成AB -背景:了解跨人群临床研究中的不良事件模式对于临床试验中的患者安全和保护以及制定适当的药物治疗、程序和治疗计划非常重要。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。采用t检验将各年龄组的发病率和多样性水平与最低组(参照组)进行比较。队列数据来自ClinicalTrials.gov，共分析了186,339项临床研究;数据来自17,853项报告临床结果的临床试验。临床试验参与者总数为6,808,619人，这些试验中受不良事件影响的参与者总数为1,840,432人。试验参与者被分为八个不同的年龄组，以支持跨年龄组比较。 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. SN - 2291-9694 UR - http://medinform.www.mybigtv.com/2016/4/e30/ UR - https://doi.org/10.2196/medinform.6437 UR - http://www.ncbi.nlm.nih.gov/pubmed/27751983 DO - 10.2196/medinform.6437 ID - info:doi/10.2196/medinform.6437 ER -