This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.
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Row 1: | Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF. | Row 2: | Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. SUPRESP is used to indicate that the use of marijuana was solicited on the CRF. | 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: | Shows the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUPRESP | SUSTAT | SUREASND | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC | SUSTRTPT | SUSTTPT | SUENRTPT | SUENTPT |
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1 | 1234 | SU | 1234005 | 1 | CIGARETTES | RECREATIONAL PRODUCT | Y |
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| 2 | PACK | QD |
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| BEFORE | 2006-01-01 | ONGOING | 2006-01-01 |
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2 | 1234 | SU | 1234005 | 2 | MARIJUNA | RECREATIONAL PRODUCT | Y |
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| 2002 | 2006-01-01 |
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3 | 1234 | SU | 1234006 | 1 | CIGARETTES | RECREATIONAL PRODUCT | Y |
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| 1 | PACK | QD |
| 2003 | BEFORE | 2006-03-15 |
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4 | 1234 | SU | 1234007 | 1 | RECREATIONAL PRODUCT | RECREATIONAL PRODUCT |
| NOT DONE | Subject left office before CRF was completed |
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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 | Were any recreational drugs used? | Any Recreational Drugs Used | Indicate if the subject had used any recreational drugs. | Text | N/A | (NY) | Yes; No | SUTRT | 3 | What was the recreational drug used? | Type of Recreational Drug Used | Record the name of the recreational drug used. | Text | SUTRT | Alcohol; Tobacco; Marijuana. Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; OTher SUNCF | 4 | Does subject use recreational drugs? | 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 | What was the amount of recreational drug used? | Amount | Indicate the amount of recreational drugs the subject consumes on a regular basis. | Text | SUDOSE; SUDOSTXT | SUDOSFRQ | 6 | What was the frequency of recreational drug use? | Frequency | Record how often the subject regularly uses recreational drugs. | Text | SUDOSFRQ | (FREQ) | QD; EVERY WEEK; QM; PA | Prompt | SUCDUR | 7 | What was the duration of recreational drug use consumption? | Duration | Provide the duration of the substance use (e.g., how long the subject has smoked). | Text | SUDUR | Prompt | SUCDURU | 8 | What was the unit of duration of recreational drug use? | Unit | Select the appropriate duration unit of the substance use. | Text | SUDUR | (UNIT) | DAYS; MONTHS; YEARS | Prompt |
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