JPRN-UMIN000035031已完成未知
Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan - Risk of SJS/TEN Associated with Anticonvulsants in Japan
Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University0 个研究点目标入组 355 人开始时间: 2018年11月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 355
研究概览
简要总结
There were increased odds of SJS/TEN in the new users of carbamazepine (OR 68.00, 95% confidence interval [CI] 8.49 to 8792.29) and lamotrigine (OR 36.00, 95% CI 3.84 to 4770.48). The ALDEN score was more than probable for 100% of cases exposed to lamotrigine or carbamazepine. The 90-day cumulative incidences of SJS/TEN per 100,000 new users were 93.83 for carbamazepine and 84.33 for lamotrigine. We found no significant elevated odds in the users of other anticonvulsants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Cohort study: None Matched case-control study: Patients who did not have an observational period of >180 days prior to the index date
研究者
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