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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 provides a mechanism for uniquely identifying a tobacco product. Only one 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 | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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| 1 | TB005 | PL | VAPE-Z01 | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | ENDS (VAPES) |
| ENDS (VAPES) |
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| | 2 | TB005 | PL | VAPE-Z01 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Closed E-Cigarette |
| Closed E-Cigarette |
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| | 3 | TB005 | PL | VAPE-Z01 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | XX Vapes USA |
| XXX Vapes USA |
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( NOTE: Meta Example to be confirmed with RM.
Example PI SUPPPI Variable Metadata
| Variable | Label | Type | Codelist |
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| DEIMDRCDPIIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| DEIMDRFL2PIIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| DEIMDRFL1PIIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | PISEQ | PILNKID | PITERM | PIDECOD | PIMODIFY | PIACT | PISTDTC |
| PIIMDRCD | PIIMDRL2 | PIIMDRL1 |
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1 | TB005 | EEPI | 2029 | VAPE-Z01 | 1 |
| Broken Heater | Mechanical Problem | Mechanical Problem | Device Replaced | 2009-12-28 |
| A05 | Mechanical Problem | Mechanical Problem |
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2 | TB005 | EEPI | 1059 | VAPE-Z01 | 1 |
| Won’t charge | | Charging Problem | Battery Replaced | 2009-01-05 |
| A0706 | Charging Problem | Electrical /Electronic Property Problem |
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3 | TB005 | EEPI | 3067 | VAPE-Z01 | 1 | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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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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This example illustrates how the coding information for a product issue might be represented. The parent domain (RDOMAIN) is PI, and IDVAR is PISEQ. 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 (PISEQ) 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 | 1996001 | PI | 2029 | PISEQ | 1 | PIIMDRCD | IMDR Code | AO5 | ASSIGNED |
| | 2 | 1996001 | PI | 2029 | PISEQ | 1 | PIIMDRL2 | IMDR Level 2 | Mechanical Problem | ASSIGNED |
| | 3 | 1996001 | PI | 2029 | PISEQ | 1 | PIIMDRL1 | IMDR Level 1 | Mechanical Problem | ASSIGNED |
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Subject 3067 had an AE associated with the battery problem. This was reported in the AE dataset. Not all variables are shown for brevity .
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