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. The sponsor added the UPC codes of the product to the dataset. Some sponsor may collects the UPC code on the CRF. The duration was represented using the ISO 8601 duration format.
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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 | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUDUR | SUENDTC | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT |
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1 | TB901 | SU | TB901005 | 2 | XYZ Menthol King Size | SMOKED TOBACCO PRODUCT | USUAL BRAND | 2P20Y | PACK | QD |
| BEFORE | 2006-01-01 | ONGOING | 2006-01-01 |
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2 | TB901 | SU | TB901006 | 3 | AAA Chewing Tobacco | SMOKELESS TOBACCO PRODUCT | NOT USUAL BRAND | 1 | CAN | EVERY WEEK | 2002 P3M | 2006-01-01 |
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The additional information was represented as findings about events (FASU). The name of the tobacco product (SUTRT) associated with the data was represented in FAOBJ. The UPC code was used by the sponsor to identify the product.
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