Transcription of How to define Treatment Emergent Adverse Event (TEAE) …
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How to define Treatment Emergent Adverse Event (TEAE) …
1 PharmaSUG 2017 - Paper IB03 How to define Treatment Emergent Adverse Event (TEAE) in crossover clinical trials? Mengya (Gillian) Yin, Ultragenyx Pharmaceutical, Novato, CA Wen Tan, Ultragenyx Pharmaceutical, Novato, CA ABSTRACT Treatment Emergent Adverse Event , TEAE, defines as an Event that emerges during Treatment , having been absent pretreatment, or worsens relative to the pretreatment state according to the E9 guideline. In crossover clinical trials, TEAE can be more complicated due to several factors such as occurrence in washout period, severity change and partial dates.
crossover clinical trials, TEAE can be more complicated due to several factors such as occurrence in washout period, severity change and partial dates. In this paper, we present these AE scenarios and give suggest solutions. General considerations as well as a conservative method for handling such scenarios
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