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Article
Signal Detection in EUROmediCAT: Identification and Evaluation of Medication–Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference
Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify tera...
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Article
Open AccessA Feasibility Study of Drug–Drug Interaction Signal Detection in Regular Pharmacovigilance
Adverse drug reactions related to drug–drug interactions cause harm to patients. There is a body of research on signal detection for drug interactions in collections of individual case reports, but limited use...
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Article
Open AccessProspective Evaluation of Adverse Event Recognition Systems in Twitter: Results from the Web-RADR Project
A large number of studies on systems to detect and sometimes normalize adverse events (AEs) in social media have been published, but evidence of their practical utility is scarce. This raises the question of t...
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Article
Open AccessRecommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR
Over a period of 3 years, the European Union’s Innovative Medicines Initiative WEB-RADR project has explored the value of social media (i.e., information exchanged through the internet, typically via online so...
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Article
Open AccessCorrection to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally publi...
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Article
Open AccessvigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues
Individual case safety reports of suspected harm from medicines are fundamental to post-marketing surveillance. Their value is directly proportional to the amount of clinically relevant information they includ...
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Article
Empirical Performance of the Calibrated Self-Controlled Cohort Analysis Within Temporal Pattern Discovery: Lessons for Develo** a Risk Identification and Analysis System
Observational healthcare data offer the potential to identify adverse drug reactions that may be missed by spontaneous reporting. The self-controlled cohort analysis within the Temporal Pattern Discovery frame...