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changes.mady.by.user Kathleen Mellars

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changes.mady.by.user Christine Connolly

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AEs were coded using MedDRA, and the sponsor’s procedures include the possibility of modifying the reported term to aid in coding. The CRF was structured so that seriousness category variables (e.g., AESDTH, AESHOSP) were checked only when AESER is answered “Y.” In this study, the study reference period started at the start of product exposure. Three AEs were reported for this subject. This SDTM dataset used AEENRF to represent Ongoing events. More information can be found in  SDTMIG Section 4.4.7, Use of Relative Timing Variables. The expected variables (e,g,, AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) were not included to save space.  

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