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Alcohol usage and tobacco product usage were represented in the SU domain. SUCAT allows the records to be grouped into tobacco -related data and alcohol related data. In this example, the products prespecified so SUTRT does not require a standardized SUDECOD equivalent. The sponsor only include SUSTDTC and SUENDTC as timing variables.
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| Row 1 1: | Shows the cigarettes used for the day of assessment. SUDOSFRQ was represented using the controlled terminology for per day, QD. | | Rows 2-3 | Show 2 other records for a subject's usage of tobacco products on two other days. | | Row 4 | Shows the subjects use of alcohol. Note, the sponsor collected the ounces of the product used using a pre-specified amount per drink. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFR | SUSTDTC | SUENDTC |
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| 1 | TLXS111 | SU | ABC-01001 | 1 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-06-26 | 2020-06-26 |
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| 2 | TLXS111 | SU | ABC-01001 | 2 | CIGAR | TOBACCO | 2 | CIGAR | QD | 2020-07-27 | 2020-07-27 |
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| 3 | TLXS111 | SU | ABC-01001 | 3 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-08-15 | 2020-07-15 |
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| 4 | TLXS111 | SU | ABC-02001 | 1 | BEER | ALCOHOL | 24 | OZ | QD | 2021-09-15 | 2021-09-15 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMMODIFY | CMCLAS | CMDOSE | CMDECOD | CMDOSU | CMDOSFRM | CMSTDTC | CMENDTC |
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| 1 | TLXS111 | CM | ABC-01007 | 1 | Nicotine Replacement Patch | Nicotine | DRUGS USED IN NICOTINE DEPENDENCE | 14 | Nicotine | mg | PATCH | 2020-06-26 | 2020-06-2627 |
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A Product Accountability (DA) domain was used to record the amount of study product transferred to or from the study subjects. At each visit the subject was supplied with 90 cartridges per week for weeks 1-3, and 50 cartridges per week for weeks 4-6. The number of cartridge returned were counted. DACAT was used to indicate that the products of interest was the study product. DASPID and DAREFID can be used for code numbers that appeared on the study product label, in this case no code numbers were used on the labels. The sponsor included VISITNUM and DADTC as these variables are expected in this domain. DADTC was the date the supplies were dispensed or returned, these corresponded to the dates of the visits.
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRQ | EXROUTE | ECPSTRGEXPSTRG | ECPSTRGUEXPSTRGU | EPOCH | EXSTDTC | EXENDTC |
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| 1 | ABC | EX | ABC1001 | 1 | INHALED NICOTINE | 137 | CARTRIDGEQD | RESPIRATORY (INHALATION) | 6 | mg | TREATMENT | 2004-06-26 | 2004-06-26 | | 2 | ABC | EX | ABC2001 | 2 | INHALED NICOTINE | 5 | CARTRIDGE | QD | RESPIRATORY (INHALATION) | 6 | mg | TREATMENT | 2011-06-27 | 2011-06-27 | | 3 | ABC | EX | ABC2002 | 1 | INHALED NICOTINE | 6 | CARTRIDGE | QD | RESPIRATORY (INHALATION) | 4 | mg | TREATMENT | 2011-08-28 | 2011-08-28 | | 4 | ABC | EX | ABC2002 | 2 | INHALED NICOTINE | 17 | CARTRIDGEQD | RESPIRATORY (INHALATION) | 4 | mg | TREATMENT | 2011-08-29 | 2011-08-29 |
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