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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.

These product malfunctions and events are represented in EM. Events not specifically associated with the product device should not be represented in this domain.     

The applicant used a standardized or dictionary-derived text for the description of an issue or events. (Note: CDISC does not prescribe what standardized or dictionary-derived text should be used.) The applicant decided to use the International Medical Device Regulators Forum (IMDRF) document terminologies for categorized adverse event reporting for 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).

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

Example SUPPEM Variable Metadata

Example External Dictionaries

The SDTM EM dataset is shown below. 

This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger.  The sponsor did not collect device events for the heatstick used in the System Holder and Charger. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. TEDCODE was the Level 3 IMDRF term. 

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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study.