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| Xformpusher |
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| Order | CDASHIG Variable | Question Text | Prompt | Data Type | CRF Completion Instructions | SDTMIG Target | SDTM Variable Mapping | Controlled Terminology Codelist Name | Permissible Values | Pre-populated Value | Query Display | List Style | Hidden |
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| 1 | SPTOBID | What was the tobacco product identifier? | Tobacco Product Identifier | text | Indicate the tobacco product that was involved in the incident. | SPTOBID |
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| VAPE-Z01 |
| radio |
| | 6 | TETERMPITERM | What was the event associated with this tobacco product? | Tobacco Product Event | text | Record a description of the event that occurred. | TETERMPITERM |
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| | 7 | TESTDATPISTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the event first occurred or was noted using this format (DD-MON-YYYY). | TESTDTCPISTDTC |
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| | 10 | TEPATTPIEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the event occurred. | TEPATTPIPATT |
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| Single Event; Intermittent; Continuous |
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| radio |
| | 11 | TEACNDEVPIACNDEV | What action was taken with the study device? | Action Taken With Device | text | Record what action was taken with the tobacco product as a result of the event. | TEACNDEVPIACNDEV |
| (DEACNDEV) | No Change; Tobacco Product Replaced;
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| radio |
| | 12 | TEAENOPIAENO(n) | What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | text | Record the ID of the primary AE associated with event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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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.
| Dataset wrap |
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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 | 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 | XX Vapes USA |
| XXX Vapes USA |
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| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | TESEQPISEQ | TETERMPITERM | TEDECODPIDECOD | TEMODIFYPIMODIFY | TEVACTPIEVACT | TESTDTCPISTDTC |
| TEIMDRCDPIIMDRCD | TEIMDRL2PIIMDRL2 | TEIMDRL1PIIMDRL1 |
|---|
1 | TB005 | TEPI | 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 | TEPI | 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 | TEPI | 3067 | VAPE-Z01 | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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| Nsvmeta |
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| | Variable | Label | Type | Role | Origin |
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| TEIMDRCDPIIMDRCD | IMDR Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | TEIMDRL2PIIMDRL2 | IMDR Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | TEIMDRL1PIIMDRL1 | IMDR Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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