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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.

Jira
showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-121

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. 

Dataset wrap
Name TO
Dataset2 Row STUDYID DOMAIN SPTOBID TOSEQ TOPARMCD TOPARM TOCAT TOVAL 1 TB123 TO VAPE-Z01 1 TBPRDCAT Tobacco Product Category PRODUCT IDENTIFIER ENDS (VAPES) 2 TB123 TO VAPE-Z01 2 TBPRSCAT Tobacco Product Subcategory PRODUCT IDENTIFIER CLOSED E-CIGARETTE 3 TB123 TO VAPE-Z01 3 MANUF Manufacturer PRODUCT IDENTIFIER XXX VAPES USA

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 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 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).

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

Example SUPPEM  Variable Metadata

Example External Dictionaries

The EM dataset is shown below. 

Dataset wrap
Name EM
Dataset2 Row STUDYID DOMAIN USUBJID SPTOBID EMSEQ EMLNKID EMTERM EMDECOD EMMODIFY EMACNDEV EMPATT EMSTDTC 1 TB123 EM 2029 VAPE-Z01 1 Broken Heater Mechanical Problem Mechanical Problem DEVICE REPLACED SINGLE 2009-12-28 2 TB123 EM 1059 VAPE-Z01 1 Won’t charge Charging Problem Charging Problem BATTERY REPLACED SINGLE 2009-01-05 3 TB123 EM 3067 VAPE-Z01 1 1 Battery Malfunction Battery Problem Battery Problem BATTERY REPLACED INTERMITTENT 2009-01-05

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. 

Dataset wrap
Name suppem
Dataset2 Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL 1 TB123 EM 2029 EMSEQ 1 EMIMDRCD IMDR Code AO5 ASSIGNED 2 TB123 EM 2029 EMSEQ 1 EMIMDRL2 IMDR Level 2 Mechanical Problem ASSIGNED 3 TB123 EM 2029 EMSEQ 1 EMIMDRL1 IMDR Level 1 Mechanical Problem ASSIGNED

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.  

Dataset wrap
Dataset2 Row STUDYID DOMAIN USUBJID SPTOBID AESEQ AELNKID AETERM AERLDEV EPOCH AESTDTC AEENDTC AESTDY AEENDY 1 TB123 AE 3067 VAPE-Z01 1 1 SKIN REDNESS RELATED PRODUCT EXPOSURE 2009-01-05 2009-01-07 14 17

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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title relrec.xpt
Row STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELTYPE RELID 1 TB005 EM EMLNKID ONE AEEM1 2 TB005 AE AELNKID ONE AEEM1