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These example SDTM datasets represent the data collected on the above CRF.

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Current type of smokeless tobacco used, Snuff, Chewing tobacco. Amount Used : Cans/pouches per week, Dips per day  Dipping tobacco is a type of finely ground or shredded, moistened smokeless tobacco product. It is commonly and idiomatically known as "dip". Dipping tobacco is used by placing a pinch, or "dip", of tobacco between the lip and the gum (sublabial administration). The act of using it is called dipping.

Other users of tobacco in household

Years of regular smokeless tobacco use

Fagerstrom Test for Nicotine Dependence (FND)    The Fagerström Tolerance Questionnaire was developed by Karl-Olov Fagerström. This instrument was modified to the Fagerström Test for Nicotine Dependence by Todd Heatherton, et al. in 1991. The FTND is copyrighted by Taylor and Francis Ltd., but may be reproduced without permission, as available from the source reference (Heatherton, et al., 1991). 

Smoking status (self-reported and biochemically validated)

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Row 1:Subject 1234005 is a 2-pack/day current smoker. “Current” implies that smoking started sometime before the time the question was asked (SUSTTPT = "2006-01-01", SUSTRTPT = "BEFORE") and had not ended as of that date (SUENTTP = "2006-01-01", SUENRTPT = "ONGOING"). See Section 4.4.7, Use of Relative Timing Variables for the use of these variables. Both the beginning and ending reference time points for this question are the date of the assessment.
Row 2:Subject 1234005 drank 3 cups of coffee on the day of the assessment.
Row 3:Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:Subject 1234006 drank tea on the day of the assessment.
Row 5:Subject 1234006 drank coffee on the day of the assessment.
Row 6:Subject 1234007 had missing data for the smoking questions; this is indicated by SUOCCUR null and SUSTAT = "NOT DONE". The reason is in SUREASND.
Row 7:Subject 1234007 also had missing data for all of the caffeine questions.
Rows 1, 3, 7, 9: Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary. 
Rows 2, 4, 5, 6, 8: Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.   
Dataset2
SUPRESPSUOCCURSMOKELESS CIGARETTES 
RowSTUDYIDDOMAINUSUBJIDSUSEQCMSEQSUTRTCMTRTSUCATCMCATCMSCATCMPRESPSUSTATCMOCCURSUREASNDCMDTCSUDOSESUDOSUSUDOSFRQSUSTDTCSUENDTCSUSTTPTSUSTRTPTSUENTPTSUENRTPTCMDUR
11234SUCM12340051CIGARETTESTOBACCODRUG USED IN NICOTINE DEPENDENCE

YY2PACKQD2006-01-01BEFORE2006-01-01ONGOING2008-08-08
21234SUCM12340052COFFEECAFFEINEYY3CUPQD2006-01-01NICOTINE PATCH XYZNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2M
2006-01-0131234SUCM12340061CIGARETTESTOBACCODRUG USED IN NICOTINE DEPENDENCE

YY1PACKQD20032006-03-15BEFORE2008-11-12
41234SUCM12340062TEACAFFEINEYY1CUPQD2006-03-152006-03-1551234SU12340063COFFEECAFFEINEYY2CUPQD2006-03-152006-03-1561234SU12340071CIGARETTESTOBACCOYNOT DONESubject left office before CRF was completed71234SU12340072CAFFEINECAFFEINEYNOT DONESubject left office before CRF was completedNICOTINE REPLACEMENT  THERAPYNICOTINEY OR N NICOTINE GUM ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P3M
51234CM12340063NICOTINE LOZENGES ABCNICOTINE REPLACEMENT THERAPYLAST ATTEMPTED USE WITH THIS MEDICATION


P2W
61234CM12340061BUPROPIONDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P1M
71234CM12340072DRUG USED IN NICOTINE DEPENDENCE

YY2008-06-12
81234CM12340073VARENICLINEDRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTSLAST ATTEMPTED USE WITH THIS MEDICATION


P40D
91234CM12340121DRUG USED IN NICOTINE DEPENDENCE

YN2008-03-05

FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

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Namefasufacm
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Rows 1, 6, 11:Rows 2-5, 7-10, 12-15:
Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFASPIDFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTCFATPTFATPTNUMFAELTMFATPTREF
1ABC1234FAABC-1231234005190567TOTNUMNUMBER NRTTOBACCO CESSATION ATTEMPTS10102007-05-165M PRE-DOSE1-PT5MDOSING2ABCFAABC-123290567OCCURAGE STARTED SMOKING ( Or Tobacco Product)  DAILY16162007-05-165M PRE-DOSE1-PT5MDOSING3ABCFAABC-123390567OCCURNUMBERPHARMACUETIALNN2007-05-165M PRE-DOSE1-PT5MDOSING4ABCFAABC-123490567OCCUROccurrence IndicatorSMO:YY2007-05-165M PRE-DOSE1-PT5MDOSING5ABCFAABC-123

5

90567OCCUROccurrence IndicatorAuraYY2007-05-165M PRE-DOSE1-PT5MDOSING6ABCFAABC-123690567SEVSeverity/IntensityMigraineMODERATEMODERATE2007-05-1630M POST-DOSE2PT30MDOSING7ABCFAABC-123790567OCCUROccurrence IndicatorSensitivity To LightYY2007-05-1630M POST-DOSE2PT30MDOSING8ABCFAABC-123890567OCCUROccurrence IndicatorSensitivity To SoundNN2007-05-1630M POST-DOSE2PT30MDOSING9ABCFAABC-123990567OCCUROccurrence IndicatorNauseaNN2007-05-1630M POST-DOSE2PT30MDOSING10ABCFAABC-1231090567OCCUROccurrence IndicatorAuraYY2007-05-1630M POST-DOSE2PT30MDOSING11ABCFAABC-1231190567SEVSeverity/IntensityMigraineMILDMILD2007-05-1690M POST-DOSE3PT90MDOSING12ABCTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE442008-08-08
21234FA12340061TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE552008-11-12
31234FA12340071TOTNUMTotal NumberDRUG USED IN NICOTINE DEPENDENCEATTEMPTS TO REDUCE NICOTINE DEPENDENCE332008-06-12FAABC-1231290567OCCUROccurrence IndicatorSensitivity To LightNN2007-05-1690M POST-DOSE3PT90MDOSING13ABCFAABC-1231390567OCCUROccurrence IndicatorSensitivity To SoundNN2007-05-1690M POST-DOSE3PT90MDOSING14ABCFAABC-1231490567OCCUROccurrence IndicatorNauseaNN2007-05-1690M POST-DOSE3PT90MDOSING15ABCFAABC-1231590567OCCUROccurrence IndicatorAuraNN2007-05-1690M POST-DOSE3PT90MDOSING