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  1. No Access

    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...

    Alana Cavadino, Lovisa Sandberg, Inger Öhman, Tomas Bergvall, Kristina Star in Drug Safety (2021)

  2. Article

    Open Access

    A 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...

    Sara Hult, Daniele Sartori, Tomas Bergvall, Sara Hedfors Vidlin in Drug Safety (2020)

  3. Article

    Open Access

    Prospective 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...

    Lucie M. Gattepaille, Sara Hedfors Vidlin, Tomas Bergvall, Carrie E. Pierce in Drug Safety (2020)

  4. Article

    Open Access

    Recommendations 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...

    John van Stekelenborg, Johan Ellenius, Simon Maskell, Tomas Bergvall in Drug Safety (2019)

  5. Article

    Open Access

    Correction 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...

    Tomas Bergvall, G. Niklas Norén, Marie Lindquist in Drug Safety (2019)

  6. Article

    Open Access

    vigiGrade: 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...

    Tomas Bergvall, G. Niklas Norén, Marie Lindquist in Drug Safety (2014)

  7. No Access

    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...

    G. Niklas Norén, Tomas Bergvall, Patrick B. Ryan, Kristina Juhlin in Drug Safety (2013)