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MedDRA |
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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). MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers Associations in the United States. As with other public data sharing similar reaction dictionaries such as MedDRA (R), Qscan(R) -VAERS integrates seamlessly and quickly with existing adverse event data-capture systems, and with clinical data management systems to allow cross comparisons and proportional analysis. |
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MedDRA
