Tobacco Product Events and Malfunctions (EM)

In tobacco studies, subjects may report problems or malfunctions with the device used to deliver the tobacco product, which may or may not result in adverse events. These may be called "events" or "malfunctions." Often the true cause of the issue cannot be determined until a cause analysis is performed. Theses device related issues or events may or may not be a concern for a given trial depending upon whether the device has already been approved by regulators. 

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.

CDASH EM Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	Any Tobacco Product Events	Any Tobacco Product Events	Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.	Text	EMYN	EMYN	N/A	(NY)	No;Yes
2	Tobacco Product Identifier	Tobacco Product Identifier	Indicate the  product that  was associated with the event.	Text	SPTOBID	SPTOBID				VAPE-Z01

Section 2 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
3	What was the event or malfunction associated with this device?	Tobacco Product Device Event	Record a description of the toboacco product device event or malfunction that occurred.	Text	EMTERM	EMTERM
4	What was the start date when the event or malfunction first occurred or was identified?	Start Date	Record the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY).	Date	EMSTDAT	EMSTDTC
5	What was the pattern of the event of malfunction?	Pattern of Tobacco Product Device Event	Record the pattern of the the event or malfunction that occurred.	Text	EMPATT	EMPATT			Single Event; Intermittent; Continuous
6	What action was taken with the device?	Action Taken With Device	Record what action was taken with the device as a result of the event.	Text	EMACNDEV	EMACNDEV		(DEACNDEV)	No Action Taken; Device Replaced; Battery Replaced
7	What was the identifier for the primary adverse event(s) associated with or related to this device event?	Related Adverse Event ID	Record the ID of the primary AE associated with event, if any.	Text	EMAENO(n)	N/A	ASSOCIATE WITH RELATED RECORD VIA RELREC

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 - 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. 

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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

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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	https://www.imdrf.org/consultations/imdrf-terminologies-categorized-adverse-event-reporting-aer-terms-terminology-structure-and-codes

The SDTM EM dataset is shown below. 

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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

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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. 

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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

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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.  

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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

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The RELREC dataset was used to record the relationship between the EM dataset and any reported AE represented in the AE dataset. 

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