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.
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
1
TB901
SU
TB901005
2
XYZ Menthol King Size
SMOKED TOBACCO PRODUCT
USUAL BRAND
P20Y
BEFORE
2006-01-01
ONGOING
2006-01-01
2
TB901
SU
TB901006
3
AAA Chewing Tobacco
SMOKELESS TOBACCO PRODUCT
NOT USUAL BRAND
P3M
2006-01-01
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
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.