The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain which provides a mechanism for uniquely identifying a tobacco product was used. Only one tobacco product was of interest in the study.
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 used a standardized or dictionary-derived text for the description of an issue or events. CDISC does not provide information on what standardized or dictionary-derived text should be used).
The sponsor 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. EMDECOD was the Level 3 IMDRF term. Non-standard variables were used to represent the various coding level variables defined in the dictionary.
( NOTE: Meta Example to be confirmed with someone - RM. )
Example SUPPEM Variable Metadata
| Variable | Label | Type | Codelist |
|---|---|---|---|
| EMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
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 |
The EM dataset is shown below.
Below is the dataset, SUPPEM, used to represent the non-standard variables used for coding the malfunction or event. The parent domain (RDOMAIN) is EM, and IDVAR is EMSEQ. QNAM holds the name of the supplemental qualifier variable being defined. This only shows the data for subject 2029. The data recorded in QVAL applies to the subject’s records, where IDVAR (EMSEQ) equals the value specified in IDVARVAL.
In this study, Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown below for brevity.
The RELREC dataset was used to record the relationship between the Tobacco Product Events and Malfunctions (EM) dataset and any reported AE represented in the AE dataset.
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