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The associated SDTM datasets for the data collected above are provided below. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is provided for reference below.
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 one 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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These product malfunctions and events are represented in the Tobacco Product Events and Malfunctions Domain (EM). Events not specifically associated with the product device should not be represented in this EM domain.
The sponsor applicant used a standardized or dictionary-derived text for the description of an issue or events. CDISC does not prescribe what standardized or dictionary-derived text should be used.
The sponsor applicant decided to use the International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes. Annex A ( 2022) provides the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element (See Section 2.10 Standards for Data Exchange).
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