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MEDDRA

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AcronymDefinition
MedDRAMedical Dictionary for Regulatory Activities
MEDDRAMedical Dictionary for Drug Regulatory Affairs


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The World Health Organization and the International Conference on Harmonization (ICH) have announced the implementation of MedDRA in the WHO global individual case safety reports (ICSR) database (Vigibase), thus completing a one-year project to make Vigibase processes as compatible with MedDRA as they are currently with WHO-ART.
FDA codes all reported adverse events using a standardized international terminology, MedDRA (the Medical Dictionary for Regulatory Activities).
Event data were defined using updated MedDRA terms and stratified by (a) no AHT (placebo n = 1,917, vardenafil n = 3,359); (b) more than 1 AHT excluding alpha-blockers (placebo n = 828, vardenafil n = 1,355); and (c) alpha-blockers alone or with more than 1 AHT (placebo n = 204, vardenafil n = 377).
 
 
 
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