| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | EMYN | Any Tobacco Product Events | Any Tobacco Product EventsRecord the type of medicaiton the subject used to reduce nicotine dependency. | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | CMCAT | | EMYN | N/A | (NY) | Yes;No |
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| 2 | SPTOBID | Tobacco Product Identifier | Tobacco Product Identifier | Indicate the product that was associated with the event. | SPTOBID |
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| VAPE-Z01 |
| 3 | EMTERM | What was the event or malfunction associated with this device? | Tobacco Product Device Event | Record a description of the toboacco product device event or malfunction that occurred. | EMTERM |
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| 4 | EMSTDAT | What was the start date when the event or malfunction first occurred or was identified? | Start Date | Record the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY). | EMSTDTC |
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| 5 | EMPATT | What was the pattern of the event of malfunction? | Pattern of Tobacco Product Device Event | Record the pattern of the the event or malfunction that occurred. | EMPATT |
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| Single Event; Intermittent; Continuous |
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| EMACNDEV | What action was taken with the device? | Action Taken With Device | Record what action was taken with the device as a result of the event. | EMACNDEV |
| (DEACNDEV) | No Action Taken; Device Replaced; Battery Replaced
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| EMAENO(n) | What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | Record the ID of the primary AE associated with event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC | NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;
2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 | What was the name of the medication the subject used to reduce nicotine dependency?
Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | 4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | DAYS; MONTHS; YEARS |
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