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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.

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Any Tobacco Product EventsAny Tobacco Product EventsIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.TextEMYNEMYNN/A(NY)No;Yes
2Tobacco Product Identifier Tobacco Product Identifier Indicate the  product that  was associated with the event. TextSPTOBIDSPTOBID


VAPE-Z01

Section 2 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
3

What was the event or malfunction associated with this device?

Tobacco Product Device EventRecord a description of the toboacco product device event or malfunction that occurred.TextEMTERMEMTERM



4What was the start date when the event or malfunction first occurred or was identified?Start DateRecord the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY).DateEMSTDATEMSTDTC



5What was the pattern of the event of malfunction?Pattern of Tobacco Product Device EventRecord the pattern of the the event or malfunction that occurred.TextEMPATTEMPATT

Single Event; Intermittent; Continuous
6What action was taken with the device?Action Taken With DeviceRecord what action was taken with the device as a result of the event.TextEMACNDEVEMACNDEV
(DEACNDEV)

No Action Taken; Device Replaced; Battery Replaced


7What was the identifier for the primary adverse event(s) associated with or related to this device event?Related Adverse Event IDRecord the ID of the primary AE associated with event, if any.TextEMAENO(n)N/AASSOCIATE 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. 

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOVAL
1TB123TOVAPE-Z01

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
2TB123TOVAPE-Z012TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERCLOSED E-CIGARETTE
3TB123TOVAPE-Z013MANUFManufacturerPRODUCT IDENTIFIERXXX 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
EMIMDRCDIMDRF CodetextIMDRFANNEXA 
EMIMDRFL2IMDRF Level 2textIMDRFANNEXA
EMIMDRFL1IMDRF Level 1textIMDRFANNEXA

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. 

em.xpt

em.xpt

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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suppem.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TB123EM2029EMSEQ1EMIMDRCDIMDR CodeAO5ASSIGNED
2TB123EM2029EMSEQ1EMIMDRL2IMDR Level 2Mechanical ProblemASSIGNED
3TB123EM2029EMSEQ1EMIMDRL1IMDR Level 1Mechanical ProblemASSIGNED
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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.  

ae.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDSPTOBIDAESEQAELNKIDAETERMAERLDEVEPOCHAESTDTCAEENDTCAESTDYAEENDY
1TB123AE3067VAPE-Z0111SKIN REDNESSRELATEDPRODUCT EXPOSURE2009-01-052009-01-071417
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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. 

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1TB005EM
EMLNKID
ONEAEEM1
2TB005AE
AELNKID
ONEAEEM1



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