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| Row 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 subject's use of alcohol. Note, the sponsor collected the ounces of the product used using a a pre-specified amount per drink. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFRQ | SUSTDTC | SUENDTC |
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| 1 | TIN111 | SU | TIN701 | 1 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-06-26 | 2020-06-26 |
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| 2 | TIN111 | SU | TIN701 | 2 | CIGAR | TOBACCO | 2 | CIGAR | QD | 2020-07-27 | 2020-07-27 |
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| 3 | TIN111 | SU | TIN801 | 1 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-07-15 | 2020-07-15 |
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| 4 | TIN111 | SU | TIN801 | 2 | BEER | ALCOHOL | 24 | OZ | QD | 2020-07-20 | 2020-07-20 |
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A Product Accountability (DA) domain was used to represent the amount of study product transferred to or from the study subjects. At each visit, each subject was supplied with 90 cartridges per week for weeks 1-3, and 50 cartridges per week for weeks 4-6. The number of cartridges returned were counted. DACAT was used to indicate that the products product of interest were 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 included 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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The sponsor used the EC domain to represent the collected exposure data. These The usage recommendations were represented in ECDOSRGM, which is the intended Dose Regimen. The ECMOOD permissible variable was used to reflect the prescribed and the actual usage of the inhaled nicotine. When this variable is used, it must be populated for all records. This variable can not cannot be used in EX.
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| Row 1: | Shows the scheduled usage recommendation for the inhaled nicotine. Note, the details on the scheduled records are described at a different level than the performed records. ECDOSRGM shows that for these start and end dates the subject was recommended to use 6-12 cartridges every day. | | Rows 2, 3: | Show the actual "performed" amount of inhaled nicotine used by the subject each day. Note only a few rows of the performed records are shown. | | Row 4: | Shows the scheduled usage recommendation for the inhaled nicotine. ECDOSRGM shows for these start and end dates the subject was recommended to use 3-6 cartridges per day.. | | Row 5: | Shows the actual "performed" amount of inhaled nicotine used by the subject each day. Note only a few rows of the performed records are shown. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | ECSEQ | ECTRT | ECMOOD | ECDOSE | ECDOSU | ECDOSFRM | ECDOSRGM | ECROUTE | EPOCH | ECSTDTC | ECENDTC |
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| 1 | TIN111 | EC | TIN701 | 1 | INHALED NICOTINE | SCHEDULED |
| CARTRIDGE | CARTRIDGE | 6 -10 cartridges per day | RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-06-26 | 2004-07-06 | | 2 | TIN111 | EC | TIN701 | 2 | INHALED NICOTINE | PERFORMED | 7 | CARTRIDGE | CARTRIDGE |
| RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-06-26 | 2004-06-26 | | 3 | TIN111 | EC | TIN701 | 3 | INHALED NICOTINE | PERFORMED | 2 | CARTRIDGE | CARTRIDGE |
| RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-06-27 | 2004-06-27 | | 4 | TIN111 | EC | TIN701 | 4 | INHALED NICOTINE | SCHEDULED |
| CARTRIDGE | CARTRIDGE | 3-6 cartridges per day | RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-07-06 | 2004-07-14 | | 5 | TIN111 | EC | TIN701 | 5 | INHALED NICOTINE | PERFORMED | 3 | CARTRIDGE | CARTRIDGE |
| RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-07-07 | 2004-07-07 |
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