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AEs were coded using MedDRA, and the applicant’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 ongoing events.The expected Expected variables (e,.g,., AELLT, AELLTCD, AEPT, AEPTCD, AEHLT, AEHLTCD, AEHLGT, AEHLCTCD, AEBDSYCD, AESOC, AESOCCD) were are not included to save space.
The applicant also collected information about whether the event was associated with a Devicedevice. These subject's subjects did not have any device-related issues. See Section 3.3.3.4, Tobacco Product Events and Malfunctions,
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