SDTM Example.Tobacco Use History

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.

Tobacco Usage History

Record the Age Category when the subject started smoking	What was the age of the subject when they started smoking? AGESTSMK__FAORRES FAORRES WHERE FATESTCD = "AGESTSMK"	16-24 years 25-34 years 45–64 years 65 years and older
Indicate whether the subject had previous tobacco cessation counseling.	Did the subject have any tobacco cessation counseling? TBCESSCO__FAORRES FAORRES WHERE FATESTCD = "TBCESSCO"	Yes No <NY codelist>
Record the longest duration of tobacco abstinence	What is the longest duration of previous abstinence from tobacco use? LDURABS__FAORRES FAORRES WHERE FATESTCD = "LDURABS"	≤7 days 8–28 days 1–6 months >6 months

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

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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

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

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

Tobacco Product Used

For each Tobacco product used, Complete the following.

Record the type of tobacco product used.	What is the type of tobacco product used by the subject? SUSCAT	SMOKED TOBACCO PRODUCT SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT)
For each product used, record the brand name of the tobacco product used.	What was the name of the tobacco product? SUTRT	BRAND X BRAND Y BRAND Z
Indicate if this is the subject's usual brand of tobacco product used	Is this the subject's usual brand of tobacco product? SUSCAT	USUAL BRAND NOT USUAL BRAND
Provide the duration of the tobacco product used	Duration FAORRES	_________________
Select the appropriate duration unit of the tobacco product used	Unit SUCDURU FAORRESU	DAYS MONTHS YEARS
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.	Is the tobacco use ongoing? SUONGO SUENRF or SUENRTPT	Yes <NY codelist>
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.	End Date SUENDAT SUENDTC	_ _ / _ _ _ / _ _ _ _

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

SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT)

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

BRAND X;BRAND Y; BRAND Z;

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

USUAL BRAND;

NOT USUAL BRAND

FAORRES

7

What was the duration of use of the tobacco product ?

Duration

Provide the duration of the tobacco product used

Text

FAORRES

Prompt

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

DAYS; MONTHS; YEARS;

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. 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

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.

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	SUENDTC	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT
1	TB901	SU	TB901005	2	XYZ Menthol King Size	SMOKED TOBACCO PRODUCT	USUAL BRAND	2	PACK	QD			BEFORE	2006-01-01	ONGOING	2006-01-01
2	TB901	SU	TB901006	3	AAA Chewing Tobacco	SMOKELESS TOBACCO PRODUCT	NOT USUAL BRAND	1	CAN	EVERY WEEK	2002	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.

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fasu.xpt

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FATESTCD	FATEST	FAOBJ	FAORRES	FAORRESU	FASTRESC	FASTRESN	FASTRESU	VISITNUM	FADTC
1	TB901	FA	TB901005	1	AGESTSMK	Age Started Smoking	TOBACCO	14	Years	14	14	Years	1	2022-7-13
2	TB901	FA	TB901005	2	TBCESSCO	Tobacco Cessation Counseling	TOBACCO	N		N			1	2022-7-13
3	TB901	FA	TB901005	3	LDURABS	Longest Duration of Abstinence	TOBACCO	>6 months		>6 months			1	2022-7-13
5	TB901	FA	TB901005	4	UPCCODE	UPC Code	XYZ Menthol King Size	974411001532		974411001532	974411001532		1	2022-7-13
7	TB901	FA	TB901005	5	UPCCODE	UPC Code	AAA Chewing Tobacco	974411001532		974411001532	974411001532		1	2022-7-13

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SDTM Example.Tobacco Use History