In tobacco studies, subjects may report events (problems) or malfunctions with the device used to deliver the tobacco product, Often the true cause of the issue cannot be determined until a cause analysis is performed. The applicant decides when tobacco product device events and malfunctions are collected. If malfunction or product event results in an adverse event, then that information should be recorded in the AE domain using the appropriate device-related variables (e.g., AEACNDEV, AERLDEV).
The Tobacco Product Events and Malfunctions (EM)) domain is based on the Events General Observation class and is used to represent device issues and/or events.
There is more than one approach to identifying tobacco product devices involved with these events/incidents. The method chosen will depend upon the granularity at which the applicant needs to track the tobacco product devices and will affect how the data are modeled. A tobacco product device can be identified as a single unit or its components can be separately identified. The level of granularity an applicant chooses will be influenced by whether the components will be replaced and/or tracked, and how tobacco product device/adverse event relationships and actions taken will be assessed.
Example
This is an example of a study where the applicant collected issues and events associated with the operation of the electronic cigarette product and any adverse events that a subject experienced as a result of the product issue or event.
This form collects events and malfunctions associated with the operation of the tobacco product device.
These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference.
TOBA-121
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Getting issue details...
STATUS
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.
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
| 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 SDTM EM dataset is shown below.
The SUPPEM dataset is used to represent the NSVs 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 EM dataset and any reported AE represented in the AE dataset.
Overview
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