Tobacco Product Events Example 1

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.

	Tobacco Product Identifier SPTOBID Pre-populated	VAPE-Z01
Record a description of the event that occurred.	What was the event associated with this tobacco product? TETERM	_________________
Record the date that the event first occurred or was noted using this format (DD-MON-YYYY).	What was the start date when the event first occurred or was identified? TESTDAT TESTDTC	_________________
Record how often the event occurred.	How frequently did the event occur? TEPATT	Single Event Intermittent Continuous
Record what action was taken with the tobacco product as a result of the event.	What action was taken with the study device? TEACNDEV	No Change Tobacco Product Replaced <DEACNDEV codelist>
Record the ID of the primary AE associated with event, if any.	What was the identifier for the primary adverse event(s) associated with or related to this device event? TEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC	_________________

Order	CDASHIG Variable	Question Text	Prompt	Data Type	CRF Completion Instructions	SDTMIG Target	SDTM Variable Mapping	Controlled Terminology Codelist Name	Permissible Values	Pre-populated Value	List Style
1	SPTOBID	What was the tobacco product identifier?	Tobacco Product Identifier	text	Indicate the tobacco product that was involved in the incident.	SPTOBID				VAPE-Z01	radio
6	TETERM	What was the event associated with this tobacco product?	Tobacco Product Event	text	Record a description of the event that occurred.	TETERM
7	TESTDAT	What was the start date when the event first occurred or was identified?	Start Date	text	Record the date that the event first occurred or was noted using this format (DD-MON-YYYY).	TESTDTC
10	TEPATT	How frequently did the event occur?	Event Frequency	text	Record how often the event occurred.	TEPATT			Single Event; Intermittent; Continuous		radio
11	TEACNDEV	What action was taken with the study device?	Action Taken With Device	text	Record what action was taken with the tobacco product as a result of the event.	TEACNDEV		(DEACNDEV)	No Change; Tobacco Product Replaced;		radio
12	TEAENO(n)	What was the identifier for the primary adverse event(s) associated with or related to this device event?	Related Adverse Event ID	text	Record the ID of the primary AE associated with event, if any.	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

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.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOSTRESC
1	TB005	TO	VAPE-Z01	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	ENDS (VAPES)	ENDS (VAPES)
2	TB005	TO	VAPE-Z01	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Closed E-Cigarette	Closed E-Cigarette
3	TB005	TO	VAPE-Z01	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	XX Vapes USA	XXX Vapes USA

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te.xpt

Row	STUDYID	DOMAIN	USUBJID	SPTOBID	TESEQ	TETERM	TEDECOD	TEMODIFY	TEVACT	TESTDTC	TEIMDRCD	TEIMDRL2	TEIMDRL1
1	TB005	TE	2029	VAPE-Z01	1	Broken Heater	Mechanical Problem	Mechanical Problem	Device Replaced	2009-12-28	A05	Mechanical Problem	Mechanical Problem
2	TB005	TE	1059	VAPE-Z01	1	Won’t charge	Charging Problem	Charging Problem	Battery Replaced	2009-01-05	A0706	Charging Problem	Electrical /Electronic Property Problem
3	TB005	TE	3067	VAPE-Z01	1	Battery Malfunction	Battery Problem	Battery Problem	Battery Replaced	2009-01-05	A0705	Battery Problem	Electrical /Electronic Property Problem

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TE NSV Metadata

Variable	Label	Type	Role	Origin
TEIMDRCD	IMDR Code	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
TEIMDRL2	IMDR Level 2	Char	Non-standard Variable Qualifier of DEDECOD	Assigned
TEIMDRL1	IMDR Level 1	Char	Non-standard Variable Qualifier of DEDECOD	Assigned

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Tobacco Product Events Example 1