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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | PISEQTOSEQ | PITESTCDTOTESTCD | PITESTTOTEST | PICATTOCAT | PIORRESTOORRES | PIORRESUTOORRESU | PISTRESCTOSTRESC | PISTRESNTOSTRESN | PISTRESUTOSTRESU |
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| 1 | TB005 | TO | VAPE-Z01 | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | ENDS (VAPES) |
| ENDS (VAPES) |
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| | 2 | TB005 | TO | VAPE-Z01 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | CLOSED E-CIGARETTE |
| CLOSED E-CIGARETTE |
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| | 3 | TB005 | TO | VAPE-Z01 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | XXX VAPES USA |
| XXX VAPES USA |
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These product issues and events are represented in the Product Issues and Events Domain (PI). Events not specifically associated with the product device should not be represented in this PI domain.
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | PISEQ | PILNKID | PITERM | PIDECOD | PIMODIFY | PIACNDEV | PIPATT | PISTDTC |
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1 | TB005 | PI | 2029 | VAPE-Z01 | 1 |
| Broken Heater | Mechanical Problem | Mechanical Problem |
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Device ReplacedDEVICE REPLACED | SINGLE | 2009-12-28 | 2 | TB005 | PI | 1059 | VAPE-Z01 | 1 |
| Won’t charge | | Charging Problem |
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Battery ReplacedBATTERY REPLACED | SINGLE | 2009-01-05 | 3 | TB005 | PI | 3067 | VAPE-Z01 | 1 | 1 | Battery Malfunction | Battery Problem | Battery Problem |
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Battery ReplacedBATTERY REPLACED | INTERMITTENT | 2009-01-05 |
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Below is the dataset, SUPPPI, used to represent the non-standad varibables used for coding the issue or event. 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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