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临床试验/DRKS00013909
DRKS00013909已完成不适用

Influence of Metabolic Profiles on Drug Safety in Routine Care - EMPAR

Bundesinstitut für Arzneimittel und Medizinprodukte0 个研究点目标入组 10,782 人开始时间: 2018年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10,782

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Age of =18 years /
  • Initial prescription of at least one anticoagulant or cholesterol lowering agent in a time frame of 01.01.2014-31.12.2017 or intake of at least one drug with verified pharmacogenetic effect, especially due to CYP2C9-, CYP2C19- und CYP2D6-variants that caused at least one Y57.9! diagnosis (ICD-10 code) in 2014-2017 /
  • Written informed consent

排除标准

  • Inapplicable metabolic profile results /
  • Oncologic phenotype (ICD 10: all C-diagnoses and D0x, D4x, D37, D38, D39) /
  • Severe F-diagnoses ( ICD 10: F0x.x, F2x.x, F7x.x, F8x.x, F31.x, F33.x, F38.x, F39.x, F42.x, F43.x, F44.x, F60.x, F61.x, F62.x, F63.x, F69.x, F91.x, F92.x, F93.x, F94.x, F95.x, F98.x, F1x.2, F1x.3, F1x.4, F1x.5, F1x.6, F1x.7, F1x.8, F1x.9, F30.1, F30.2, F30.8, F30.9, F32.2, F32.3, F32.8, F32.9, F34.8 ,F34.9, F45.2, F45.4, F45.8, F45.9, F48.1, F48.8, F48.9, F50.4, F50.5, F53.1, F53.8, F53.9, F65.2, F65.3, F65.4, F65.6, F65.8, F65.9, F68.1, F68.8, F90.1) /
  • Known genetic hematopoietic diseases upon initial prescription of anticoagulant (ICD 10 Code: D55, D56 D57, D58, D61.0, D64.0, D64.4, D66, D67, D68.0, D68.1, D68.2, D71, D72.0, D74.0, D80.0, D82) /
  • Y69! diagnosis (Unspecified misadventure during surgical and medical care) in parallel with Y57.9! diagnosis /
  • Myopathy, myositis or muscle pain before initial prescription of cholesterol lowering agents (ICD 10 Code: M60.1, M60.8, M60.9, G72.0, M62.8, M62.9, M79.1, M79.7) /
  • Criteria due to TK customer management

研究者

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