The example SDTM datasets used to represent the collected data are shown below.
SUTRT represents the brand name of the tobacco product. The applicant added the UPC code of the product to the dataset. Some applicants may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The applicant used the first visit date to populate SUSTPT and SUENTPT.
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| Row 1: | Shows that the subject used the tobacco product shown in SUTRT. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing, | | Row 2: | Shows that the subject used smokeless tobacco product shown in SUTRT. This was not the subject's usual brand of smokeless tobacco product. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUSCAT | SUDUR | SUENDTC | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT |
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| 1 | TB901 | SU | TB901005 | 1 | XYZ Menthol King Size | SMOKED TOBACCO PRODUCT | USUAL BRAND | P20Y |
| BEFORE | 2006-01-01 | ONGOING | 2006-01-01 |
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| 2 | TB901 | SU | TB901006 | 2 | AAA Chewing Tobacco | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND | P3M | 2006-01-01 | BEFORE | 2006-01-01 |
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The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO". Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.
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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 therapies 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.
SUCAT allows the records to be grouped into smoking-related data and other substances of abuse that may be collected.
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| title | Tobacco Usage History |
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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 |
SUCAT | 1 | What is the category for the substance? | Substance Use Category | Text | SUCAT | TOBACCO | SUSCAT | 1 | What is the type of tobacco product used by the subject? | Substance Use Subcategory | Record the type of tobacco product used | Text | SUSCAT | Smoked tobacco product;
Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product
SUTRT | 4 | What was the name of the tobacco product?
Substance Treatment | Record the brand name of the tobacco product used. | Text | SUTRT | CSUSCAT | 5 | Was this the subject usual brand of tobacco product? | Usual Brand | Indicate if this is the subject usual brand of tobacco product used | Text | SUSCAT | (NY) | Yes; No | SUDUR | 5 | What was the duration of use of the tobacco product ? | Duration | Provide the duration of the tobacco product used | Text | SUDOSFRQ | QD; EVERY WEEK; QM; PA | Prompt | SUCDURU | 6 | What was the unit of duration of use of the tobacco product? | Unit | Select the appropriate duration unit of the tobacco product used | Text | SUDUR | DAYS; MONTHS; YEARS | Prompt | SUDOSFRQ | 8 | What was the frequency of the tobacco product used ? | Frequency | (FREQ) | QD; EVERY WEEK; QM; PA | Prompt | 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 and the end date should be left blank. | Text | SUENRF; SUENRTPT | SUENRF or SUENRTPT | (NY) | Yes | checkbox | 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 | prompt | | Dataset wrap |
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| Row 1: | Shows that the subject previously used this tobacco product. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing, |
| Row 2: | Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. |
| Row 3: | Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC. |
Rows 4 & 5: | Show the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND. | | Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | FASEQ |
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SPTOBIDSUSEQSUTRTSUCATSUSCATSUOCCURSUSTATSUREASNDSUDOSESUDOSUSUDOSFRQSUSTDTCSUENDTCSUSTTPTSUSTRTPTSUENTPTSUENRTPT1TB784SUTB005 | BAND XYXBRAND XYZ CIGARTTES | SMOKED TOBACCO PRODUCT | USUAL BRAND | Y | 2 | PACK | QD | 2006-01-01 | | 2 | TB901 | FA | TB901005 | | TBCESSCO | Tobacco Cessation Counseling | TOBACCO | N |
| N |
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| 1 | 2006-01-01 |
BEFORE| 3 | TB901 | FA | TB901005 | | LDURABS | Longest Duration of Abstinence | TOBACCO | >6 months |
| >6 months |
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| 1 | 2006-01-01 |
ONGOING | 2 | TB784 | SU | TB006 | BRAND ZZZ | 1 | CHEWING TOBACCO BRAND ZZZ | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND | Y | 2002 | | 4 | TB901 | FA | TB901005 | 4 | UPCCODE | UPC Code | XYZ Menthol King Size | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 2006-01-01 | | 5 | TB901 | FA | TB901005 | 5 | UPCCODE | UPC Code | AAA Chewing Tobacco | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 2006-01-01 |
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