NCT02871232Unknown不适用
Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS): RADARS® System Surveillance Protocol
ER/LA Opioid REMS Program Companies (RPC)0 个研究点目标入组 26,500 人开始时间: 2016年8月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26,500
- 主要终点
- Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
研究概览
简要总结
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics. Briefly, therefore, the overall surveillance objective is to evaluate for trends before and after the shared REMS is implemented to collectively assess for changes in abuse, misuse, overdose, addiction, and death for different risk groups and settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with data in the RADARS system
排除标准
- 未提供
结局指标
主要结局
Poisson regression will be used to compare changes in rates of abuse, misuse, overdose, and death and other outcomes over time within the ER/LA opioid group to changes in rates among the comparator groups
时间窗: Review over period from January 2010 to December 2016
次要结局
- Mean number of dosing units per prescriptions dispensed across time for the ER/LA REMS drug group(Review over period from January 2010 to December 2016)
研究者
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