This is an example of a study were the sponsor collected events associated with the operation of the electronic cigarette device.
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What was the event associated with this tobacco product?
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The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain is a study reference dataset that These SDTM datasets represent the data collected above. An abbreviated Tobacco Product Identifiers and Descriptors (TO) domain example is also provided for reference. Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-121 |
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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. Only one 1.1, Tobacco Product Identifiers and Descriptors. Only 1 tobacco product was of interest in the study. Note this identifier also describes any device use by the subject to deliver the tobacco.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCDTOPARMCD | TOTESTTOPARM | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU | TOVAL |
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1 | TB005TB123 | TO | VAPE-Z01 | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | ENDS (VAPES) | ENDS (VAPES) | 2 | TB005TB123 | TO | VAPE-Z01 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Closed CLOSED E-CigaretteClosed E-CigaretteCIGARETTE | 3 | TB005TB123 | TO | VAPE-Z01 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | XX Vapes USA | XXX Vapes USA | 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 theThe 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 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 DEDCODE was the Level 3 IMDRF term. NSVs were used to represent the various coding level variables defined in the dictionary.
Example PI SUPPEM Variable Metadata
Variable | Label | Type | Codelist |
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DEIMDRCDEMIMDRCD | IMDRF Code | text | IMDRFANNEXA |
DEIMDRFL2EMIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
DEIMDRFL1EMIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
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The SDTM EM dataset is shown below.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID |
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PISEQPILNKIDPITERMPIDECODPIMODIFYPIACTPISTDTC | PIIMDRCD | PIIMDRL2 | PIIMDRL1TB005PIEM | 2029 | VAPE-Z01 | 1 |
| Broken Heater | Mechanical Problem | Mechanical Problem | Device ReplacedDEVICE REPLACED | SINGLE | 2009-12-28 |
A05 | Mechanical ProblemMechanical Problem | TB005PIEM | 1059 | VAPE-Z01 | 1 |
| Won’t charge | | Charging Problem | Battery ReplacedBATTERY REPLACED | SINGLE | 2009-01-05 | A0706Charging Problem | Electrical /Electronic Property Problem | TB005PIEM | 3067 | VAPE-Z01 | 1 | 1 | Battery Malfunction | Battery Problem | Battery Problem | BATTERY REPLACED | Battery ReplacedA0705 | Battery Problem | Electrical /Electronic Property Problem | | Nsvmeta |
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| Variable | Label | Type | Role | Origin |
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PIIMDRCD | IMDR Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | PIIMDRL2 | IMDR Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | PIIMDRL1 | IMDR Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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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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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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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 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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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | AESEQ | AELNKID | AETERM | AERLDEV | EPOCH | AESTDTC | AEENDTC | AESTDY | AEENDY |
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AEENRFTB005TB123 | AE | 3067 | VAPE-Z01 | 1 | 1 | SKIN | REDNESS SCREENINGREDNESS | RELATED | PRODUCT EXPOSURE | 2009-01-05 | 2009-01-07 | -1-1 |
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The RELREC dataset was used to record the relationship between the Product Events in PI and EM dataset and any reported AE represented in the AE dataset.