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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.  

Tobacco Usage History
Record the Age Category when the subject started smokingWhat was the age of the subject when they started smoking?
AGESTSMK__FAORRES FAORRES WHERE FATESTCD = "AGESTSMK"
Indicate whether the subject had previous tobacco cessation counseling.Did the subject have any tobacco cessation counseling?
TBCESSCO__FAORRES FAORRES WHERE FATESTCD = "TBCESSCO"
<NY codelist>
Record the longest duration of tobacco abstinenceWhat is the longest duration of previous abstinence from tobacco use?
LDURABS__FAORRES FAORRES WHERE FATESTCD = "LDURABS"
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
AGESTSMK__FAORRES1What was the age of the subject when they started smoking?  Age Started SmokingRecord the Age Category when the subject started smoking
FAORRES;FATEST;FATESTCDFAORRES WHERE FATESTCD = "AGESTSMK"
16-24 years; 25-34 years; 45–64 years; 65 years and older

radio
TBCESSCO__FAORRES2Did the subject have any tobacco cessation counseling?Tobacco Cessation Counseling Indicate whether the subject had previous tobacco cessation counseling.
FAORRES;FATEST;FATESTCDFAORRES WHERE FATESTCD = "TBCESSCO"(NY)Yes; No



LDURABS__FAORRES3What is the longest duration of previous abstinence from tobacco use? Longest Duration of  AbstinenceRecord 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 usedWhat is the type of tobacco product used by the subject?
SUSCAT
For each product used, record the brand name of the tobacco product used.What was the name of the tobacco product?
SUTRT
Indicate if this is the subject usual brand of tobacco product usedIs this the subject usual brand of tobacco product?
SUSCAT
Provide the duration of the tobacco product used
FAORRES
_________________
Select the appropriate duration unit of the tobacco product usedUnit
SUCDURU FAORRESU
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.Is the tobacco use ongoing?
SUONGO SUENRF or SUENRTPT
<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.
SUENDAT SUENDTC
_ _ / _ _ _ / _ _ _ _
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
SUSCAT4What is the type of tobacco product used by the subject? Substance Use SubcategoryRecord the type of tobacco product usedTextSUSCAT

Smoked tobacco product;

Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product 







SUTRT5What was the name of the tobacco product? 

Substance Treatment For each product used, record the brand name of the tobacco product used.  TextSUTRT

BRAND X;BRAND; BRAND Z;    



SUSCAT6Is this the subject usual brand of tobacco product? Substance Use Subcategory   Indicate if this is the subject usual brand of tobacco product usedTextSUSCAT


USUAL BRAND; 

NOT USUAL BRAND





FAORRES7What was the duration of use of the tobacco product ?  DurationProvide the duration of the tobacco product usedTextFAORRES



Prompt

SUCDURU8What was the unit of duration of use of the tobacco product?UnitSelect the appropriate duration unit of the  tobacco product usedTextFAORRESU

DAYS; MONTHS; YEARS;
Prompt

SUONGO9Is the tobacco use ongoing?OngoingRecord 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.TextSUENRF;  SUENRTPTSUENRF or SUENRTPT(NY)Yes

checkbox
SUENDAT10What was the end date?End DateRecord 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.DateSUENDTC



prompt

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 usual brand of smokeless tobacco product.
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Row

STUDYID

DOMAIN

USUBJID

SPTOBID

SUSEQ

SUTRT

SUCAT

SUSCAT

SUDOSE

SUDOSU

SUDOSFRQ

SUSTDTC

SUENDTC

SUSTTPT

SUSTRTPT

SUENTPT

SUENRTPT

1TB901SUTB901005BAND XYZ1BRAND XYZ CIGARTTESSMOKED TOBACCO PRODUCTUSUAL BRAND2PACKQD

2006-01-01BEFORE2006-01-01ONGOING
2TB901SUTB901006BRAND ZZZ1SNUS TOBACCO BRAND ZZZ SMOKELESS TOBACCO PRODUCTNOT USUAL BRAND1CANEVERY WEEK2002 2006-01-01



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In this situation, the sponsor maintained an in-house dictionary of tobacco brands. This allowed this sponsor to study products across studies using the same tobacco product code for each brand of tobacco product.  These codes were used to create a TO domain. This domain provided details on the brand of tobacco product used by the subject. Data for two brands of tobacco are shown. 
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to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1TB901TOBRAND XYZ

1

TBPRDCATTobacco Product CategoryBRAND IDENTIFIERCigarette
Cigarette

2TB901TOBRAND XYZ2TBPRSCATTobacco Product SubcategoryBRAND IDENTIFIER Filtered,Combusted
Filtered, Combusted

3TB901TOBRAND XYZ3MANUFManufacturerBRAND IDENTIFIERBrand XYZ Company
Brand XYZ Company

4TB901TOBRAND XYZ4TRADENAMTrade NameBRAND IDENTIFIERXYZ Menthol King Size
XYZ Menthol King Size

1TB901TOBRAND ZZZ1TBPRDCATTobacco Product CategoryBRAND IDENTIFIERSmokeless Tobacco Product
Smokeless Tobacco Product

2TB901TOBRAND ZZZ2TBPRSCATTobacco Product SubcategoryBRAND IDENTIFIERSnus,portioned
Snus, portioned

3TB901TOBRAND ZZZ3MANUFManufacturerBRAND IDENTIFIERZZZ Smokeless
ZZZ Smokeless




UPC 1111TBPRDCATTobacco Product CategoryBRAND IDENTIFIERCigarette



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