These example SDTM datasets represent the data collected on the above CRF.
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Modelling of this information needs discussion at ISMT. Should this be related to SU using FASU, Should the NRT be recorded in CM, or SU. How to represent in SUCAT Should SUCAT always be TOBACCO... can Nicotine be used. |
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Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping Collected with Check all that appy in CDASH.
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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| 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 |
SUCAT | 1 | What is the category of the substance used? | Substance Use Category | Record the Substance Used category, if not pre-printed on the CRF. | Text | SUCAT | Recreational Drugs | SUYN | 2 | Age subject began smoking daily | Any Recreational Drugs Used | Indicate if the subject had used any recreational drugs. | Text | N/A | (NY) | Yes; No | SUTRT | 3 | Average number of cigarettes
smoked per day over the past year | Type of Recreational Drug Used | Record the name of the recreational drug used. | Text | SUTRT | SUNCF | 4 | Has the subject attempted to quit
with the use of Nicotine Replacement
Therapy (NRT)? List details of NRT
products used in Comments section | Usage | Check the appropriate box to indicate if the subject currently or formerly used recreational drugs. | Text | SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF | SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER". | (NCF) | Current; Former | Prompt | SUDSTXT | 5 | Has the subject attempted to quit
with the use of pharmaceuticals
other than NRTs? List details of
other pharmaceuticals used in the
Comments section. | Amount | Indicate the amount of recreational drugs the subject consumes on a regular basis. | Text | SUDOSE; SUDOSTXT | SUDOSFRQ | 6 | Has the subject attempted to quit
with the use of other smoking
cessation aids? List details of other
smoking cessation aids used in the
Comments section. | Frequency | Record how often the subject regularly uses recreational drugs. | Text | SUDOSFRQ | (FREQ) | QD; EVERY WEEK; QM; PA | Prompt | SUCDUR | 7 | Has the subject made any other
attempts to quit smoking? List details
of other quit attempts in the
Comments section. | Duration | Provide the duration of the substance use (e.g., how long the subject has smoked). | Text | SUDUR | Prompt | | Dataset wrap |
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| 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. |
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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. | | Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQCMSEQ | SUTRTCMTRT | SUCATCMCAT | SUPRESPCMSCAT | SUOCCURCMPRESP | SUSTATCMOCCUR | SUREASNDCMDTC | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTTPT | SUSTRTPT | SUENTPT | SUENRTPT | CMDUR |
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| 1 | 1234 | SUCM | 1234005 | 1 | CIGARETTES | TOBACCODRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2 | PACK | QD | 2006-01-01 | BEFORE | 2006-01-01 | ONGOING | 2008-08-08 |
| | 2 | 1234 | SUCM | 1234005 | 2 | COFFEE | CAFFEINE | Y | Y | 3 | CUP | QD | 2006-01-01 | NICOTINE PATCH XYZ | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P2M | | 3 | 1234 | CM | 2006-01-01 | 3 | 1234 | SU | 1234006 | 1 | CIGARETTES | TOBACCODRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 1 | PACK | QD | 2003 | 2006-03-15 | BEFORE2008-11-12 |
| | 4 | 1234 | SUCM | 1234006 | 2 | TEA | CAFFEINE | Y | Y | 1 | CUP | QD | 2006-03-15 | 2006-03-15 | 5 | 1234 | SU | 1234006 | 3 | COFFEE | CAFFEINE | Y | Y | 2 | CUP | QD | 2006-03-15 | 2006-03-15 | 6 | 1234 | SU | 1234007 | 1 | CIGARETTES | TOBACCO | Y | NOT DONE | Subject left office before CRF was completed | 7 | 1234 | SU | 1234007 | 2 | CAFFEINE | CAFFEINE | Y | NOT DONE | Subject left office before CRF was completed | NICOTINE REPLACEMENT THERAPY | NICOTINE | Y OR N | SMOKELESS CIGARETTES | Y or N NICOTINE GUM ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P3M | | 5 | 1234 | CM | 1234006 | 3 | NICOTINE LOZENGES ABC | NICOTINE REPLACEMENT THERAPY | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P2W | | 6 | 1234 | CM | 1234006 | 1 | BUPROPION | DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P1M | | 7 | 1234 | CM | 1234007 | 2 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | Y | 2008-06-12 |
| | 8 | 1234 | CM | 1234007 | 3 | VARENICLINE | DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS | LAST ATTEMPTED USE WITH THIS MEDICATION |
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| P40D | | 9 | 1234 | CM | 1234012 | 1 | DRUG USED IN NICOTINE DEPENDENCE |
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| Y | N | 2008-03-05 |
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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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Rows 1, 6, 11: | Rows 2-5, 7-10, 12-15: | | Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | FASEQFASPID | FATESTCD | FATEST | FAOBJ | FACAT | FAORRES | FASTRESC | FADTC | FATPT | FATPTNUM | FAELTM | FATPTREF |
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| 1 | ABC1234 | FA | ABC-1231234005 | 1 | 90567TOTNUM | NUMBER | NRT | TOBACCO CESSATION ATTEMPTS | 10 | 10 | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | 2 | ABC | FA | ABC-123 | 2 | 90567 | OCCUR | AGE STARTED SMOKING ( Or Tobacco Product) DAILY | 16 | 16 | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | 3 | ABC | FA | ABC-123 | 3 | 90567 | OCCUR | NUMBER | PHARMACUETIAL | TOBACCO CESSATION ATTEMPTS | N | N | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 4 | 4 | 2008-08-08 | | 2 | 1234 | FA | 1234006 | 1 | TOTNUM | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 5 | 5 | 2008-11-12 | | 3 | 1234 | FA | 1234007 | 1 | TOTNUM | Total Number | DRUG USED IN NICOTINE DEPENDENCE | ATTEMPTS TO REDUCE NICOTINE DEPENDENCE | 3 | 3 | 2008-06-12 | 4 | ABC | FA | ABC-123 | 4 | 90567 | OCCUR | Occurrence Indicator | Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING | 5 | ABC | FA | ABC-123 | | 90567 | OCCUR | Occurrence Indicator | Y | Y | 2007-05-16 | 5M PRE-DOSE | 1 | -PT5M | DOSING |
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