This example illustrates how typical tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapy for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco strips. Usage of these products are represented in the SU domain.
| Panel |
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| title | Tobacco Usage History |
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| Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | | AGESTSMK__FAORRES | 1 | What was the age of the subject when they started smoking? | Age Started Smoking | Record the Age Category when the subject started smoking |
| FAORRES;FATEST;FATESTCD | FAORRES WHERE FATESTCD = "AGESTSMK" |
| 16-24 years; 25-34 years; 45–64 years; 65 years and older |
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| radio |
| | TBCESSCO__FAORRES | 2 | Did the subject have any tobacco cessation counseling? | Tobacco Cessation Counseling | Indicate whether the subject had previous tobacco cessation counseling. |
| FAORRES;FATEST;FATESTCD | FAORRES WHERE FATESTCD = "TBCESSCO" | (NY) | Yes; No |
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| | LDURABS__FAORRES | 3 | What is the longest duration of previous abstinence from tobacco use? | Longest Duration of Abstinence | Record the longest duration of tobacco abstinence |
| FAORRES;FATEST;FATESTCD where FASCAT= "TOBACCO" | FAORRES WHERE FATESTCD = "LDURABS" |
| ≤7 days; 8–28 days;1–6 months; >6 months |
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| Panel |
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| title | Tobacco Product Used |
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For each Tobacco product used, Complete the following. | Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | | SUSCAT | 4 | What is the type of tobacco product used by the subject? | Substance Use Subcategory | Record the type of tobacco product used. | Text | SUSCAT |
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| SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT) |
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| | SUTRT | 5 | What was the name of the tobacco product?
| Substance Treatment | For each product used, record the brand name of the tobacco product used. | Text | SUTRT |
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| BRAND X;BRAND Y; BRAND Z; |
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| | SUSCAT | 6 | Is this the subject's usual brand of tobacco product? | Substance Use Subcategory | Indicate if this is the subject's usual brand of tobacco product used | Text | SUSCAT |
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| USUAL BRAND; NOT USUAL BRAND |
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| | FAORRES | 7 | What was the duration of use of the tobacco product ? | Duration | Provide the duration of the tobacco product used | Text | FAORRES |
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| | SUCDURU | 8 | What was the unit of duration of use of the tobacco product? | Unit | Select the appropriate duration unit of the tobacco product used | Text | FAORRESU |
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| DAYS; MONTHS; YEARS; |
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| | SUONGO | 9 | Is the tobacco use ongoing? | Ongoing | Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection. The end date should be left blank. | Text | SUENRF; SUENRTPT | SUENRF or SUENRTPT | (NY) | Yes |
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| | SUENDAT | 10 | What was the end date? | End Date | Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank. | Date | SUENDTC |
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This is an example SDTM dataset used to represent the data. SUTRT captures the verbatim or the prespecified text collected for the substance, in this case the brand name of the tobacco product.
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