BAHAMA: A Bayesian Hierarchical Model for the Detection of MedDRA®-Coded Adverse Events in Randomized Controlled Trials
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Link
https://link.springer.com/content/pdf/10.1007/s40264-022-01208-w.pdf
Reference16 articles.
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2. MedDRA MSSO. Medical Dictionary for Regulatory Activities Terminology (MedDRA). 2022. http://www.meddramsso.com.
3. Pearson RK, et al. Influence of the MedDRA hierarchy on pharmacovigilance data mining results. Int J Med Inform. 2009;78(12):e97–103. https://doi.org/10.1016/j.ijmedinf.2009.01.001.
4. Chen W, et al. A Bayesian group sequential approach to safety signal detection. J Biopharm Stat. 2013;23(1):213–30. https://doi.org/10.1080/10543406.2013.736813.
5. Wang W, Heyse JF, Ibrahim JG. Efficient methods for signal detection from correlated adverse. Biometrics. 2019. https://doi.org/10.1111/biom.13031.
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1. New approach for detecting MedDRA-coded AEs in RCTs;Reactions Weekly;2022-07
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