This is an example SDTM dataset used to represent the data. SUTRT represents the brand name of the tobacco product. The sponsor added the UPC code of the product to the dataset. Some sponsor may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The sponsor used the first visit date to populate SUSTPT and SUENTPT.
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Row 1: | Shows that the subject 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 that the subject used this smokeless tobacco product. 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 sponsor 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 sponsor to identify the product. FADTC is the date of collection, in this situation the sponsor used the visit date.
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| Row | STUDYID | DOMAIN | USUBJID | FASEQ | FATESTCD | FATEST | FAOBJ | FAORRES | FAORRESU | FASTRESC | FASTRESN | FASTRESU | VISITNUM | FADTC |
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1 | TB901 | FA | TB901005 | | AGESTSMK | Age Started Smoking | TOBACCO | 14 | Years | 14 | 14 | Years | 1 | 20222006-701-1301 | 2 | TB901 | FA | TB901005 | | TBCESSCO | Tobacco Cessation Counseling | TOBACCO | N |
| N |
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| 1 | 20222006-701-1301 | 3 | TB901 | FA | TB901005 | | LDURABS | Longest Duration of Abstinence | TOBACCO | >6 months |
| >6 months |
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| 1 | 20222006-701-1301 | 4 | TB901 | FA | TB901005 | 4 | UPCCODE | UPC Code | XYZ Menthol King Size | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 20222006-701-1301 | 5 | TB901 | FA | TB901005 | 5 | UPCCODE | UPC Code | AAA Chewing Tobacco | 974411001532 |
| 974411001532 | 974411001532 |
| 1 | 20222006-701-1301 |
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