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changes.mady.by.user Jon Neville

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changes.mady.by.user Kathleen Mellars

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Dataset wrap
NameTO
Dataset2
RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1TB123TOVAPE-Z01

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERENDS (VAPES)
ENDS (VAPES)

2TB123TOVAPE-Z012TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERCLOSED E-CIGARETTE
CLOSED E-CIGARETTE

3TB123TOVAPE-Z013MANUFManufacturerPRODUCT IDENTIFIERXXX VAPES USA
XXX VAPES USA

These product issues 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.     

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Below is the dataset, SUPPEM, used to represent the non-standad varibables standard variables used for coding the issue 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
Namesuppem
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1TB123EM2029EMSEQ1EMIMDRCDIMDR CodeAO5ASSIGNED
2TB123EM2029EMSEQ1EMIMDRL2IMDR Level 2Mechanical ProblemASSIGNED
3TB123EM2029EMSEQ1EMIMDRL1IMDR Level 1Mechanical ProblemASSIGNED

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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