On estimands and the analysis of adverse events in the presence of varying follow‐up times within the benefit assessment of therapies

The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading conclusions about a therapy's safety and consequently its benefit‐risk ratio. The statistical analysis of AEs is complicated by the...

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Detalhes bibliográficos
Publicado no:Pharm Stat
Main Authors: Unkel, Steffen, Amiri, Marjan, Benda, Norbert, Beyersmann, Jan, Knoerzer, Dietrich, Kupas, Katrin, Langer, Frank, Leverkus, Friedhelm, Loos, Anja, Ose, Claudia, Proctor, Tanja, Schmoor, Claudia, Schwenke, Carsten, Skipka, Guido, Unnebrink, Kristina, Voss, Florian, Friede, Tim
Formato: Artigo
Idioma:Inglês
Publicado em: John Wiley and Sons Inc. 2018
Assuntos:
Main Papers
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6587465/
https://ncbi.nlm.nih.gov/pubmed/30458579
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/pst.1915
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