| アブストラクト | A prospective pharmacovigilance signal detection study, comparing the real-world healthcare data (EU-ADR) and two spontaneous reporting system (SRS) databases, US FDA's Adverse Event Reporting System and WHO's Vigibase is reported. The study compared drug safety signals found in the EU-ADR and SRS databases. The potential for signal detection in the EU-ADR system was found to be dependent on frequency of the event and utilization of drugs in the general population. The EU-ADR system may have a greater potential for detecting signals for events occurring at higher frequency in general population and those that are commonly not considered as potentially a drug-induced event. Factors influencing various differences between the datasets are discussed along with potential limitations and applications to pharmacovigilance practice. |
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| ジャーナル名 | Expert review of clinical pharmacology |
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| Pubmed追加日 | 2014/12/10 |
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| 投稿者 | Patadia, Vaishali K; Coloma, Preciosa; Schuemie, Martijn J; Herings, Ron; Gini, Rosa; Mazzaglia, Giampiero; Picelli, Gino; Fornari, Carla; Pedersen, Lars; van der Lei, Johan; Sturkenboom, Miriam; Trifiro, Gianluca |
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| 組織名 | Department of Medical Informatics, Erasmus University Medical Center, Rotterdam,;the Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/25487079/ |
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