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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.
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. Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-121
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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 |
---|---|---|---|
EMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
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Codelist | External Dictionary Name | Dictionary Version | Reference |
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IMDRFANNEXA | IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes: Annex A | Release Number: 2022 |
The SDTM EM dataset is shown below.
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