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These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.

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keyTOBA-121
TO provides a mechanism for uniquely identifying a tobacco product , and is the source of the SPTOBID variable. For more information on this domain, see Section 3.1.1, Tobacco Product Identifiers and Descriptors. Only 1 tobacco product was of interest in the study. 

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EMDECOD was the Level 3 IMDRF term. NSVs were used to represent the various coding level variables defined in the dictionary. 

Example SUPPEM  SUPPEM Variable Metadata

Variable Label Type Codelist
EMIMDRCDIMDRF CodetextIMDRFANNEXA 
EMIMDRFL2IMDRF Level 2textIMDRFANNEXA
EMIMDRFL1IMDRF Level 1textIMDRFANNEXA

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Codelist

External Dictionary Name

Dictionary Version

Reference

IMDRFANNEXA IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes: Annex A 

Release Number: 2022

https://www.imdrf.org/consultations/imdrf-terminologies-categorized-adverse-event-reporting-aer-terms-terminology-structure-and-codes

The SDTM EM dataset is shown below. 

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