In this study, subjects were randomized to different doses of a nicotine inhaler. The recommended usage instruction instructions for the nicotine inhaler were was provided to the subject at each visit. At visit 1-3 subjects were to use 6-10 cartridges per day, and during visit 4-6 subjects were to use 3-6 cartridges per day. Subjects were encouraged to not to use any other tobacco products, nicotine replacement therapies or alcohol during the study. Data on usage of these products were collected using an e-diary, where the subject provided information on the products used each day. Only days where a product was used were represented.
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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 pre-specified amount per drink. |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFRSUDOSFRQ | 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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Drugs used in to treat nicotine dependency are considered medically acceptable drugs and were represented in the Concomitant Medication (CM) domain. This subject used a 14 mg nicotine replacement patch. The sponsor included the CMCLACMCLASS, CMDECOD, and CM MODIFYCMMODIFY. These were included to reflect standardized coding of the medication.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CMSEQ | CMTRT | CMMODIFY | CMDECOD | CMCLAS | CMDOSECMDECOD | CMDOSU | CMDOSFRM | CMSTDTC | CMENDTC |
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| 1 | TIN111 | CM | TIN701 | 1 | Nicotine Replacement Patch | Nicotine | NICOTINE | DRUGS USED IN NICOTINE DEPENDENCE | 14 | Nicotine | mg | PATCH | 2020-06-26 | 2020-06-27 |
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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 returned were counted. DACAT was used to indicate that the products of interest was were 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 include 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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| Rows 1, 3: | Show the number of cartridges dispensed to the subject. | | Rows 2, 4: | Show the number of cartridges returned by the subject. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | DASEQ | DATESTCD | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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| 1 | TIN111 | DA | TIN701 | | DISPAMT | Dispensed Amount | STUDY PRODUCT | 90 | CARTRIDGE | 60 | 60 | CARTRIDGE | 1 | 2004-06-26 | | 2 | TIN111 | DA | TIN701 | | RETAMT | Returned Amount | STUDY PRODUCT | 13 | CARTRIDGE | 24 | 24 | CARTRIDGE | 2 | 2020-07-06 | | 3 | TIN111 | DA | TIN701 | | DISPAMT | Dispensed Amount | STUDY PRODUCT | 90 | CARTRIDGE | 80 | 80 | CARTRIDGE | 2 | 2020-07-06 | | 4 | TIN111 | DA | TIN701 | | RETAMT | Returned Amount | STUDY PRODUCT | 10 | CARTRIDGE | 34 | 34 | CARTRIDGE | 3 | 2020-07-14 |
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The recommended usage instruction for the inhaled nicotine were provided to the subject at each visit. At visit 1-3, subjects were to use 6 -10 cartridges per day, and during visit 4-6 subjects were to use 3-6 cartridges per day. The sponsor used the EC domain to represent the collected exposure data. These usage recommendations were represented in DOSRGMECDOSRGM, which is the intended Dose Regimen. The ECMOOD permissible variable was used to reflect the intended usage recommendations 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 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 that for these start and end dates the subject was recommended to use 3-6 cartridges 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 | ECDOS | ECDOSU | ECDOSFRM | ECDOSFREQ | 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 | QD |
| IRESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-06-26 | 2004-06-26 | | 3 | TIN111 | EC | TIN701 | 3 | INHALED NICOTINE | PERFORMED | 2 | CARTRIDGE | CARTRIDGE | QD |
| IRESPIRATORY (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 | 2004-07-2014 | | 5 | TIN111 | EC | TIN701 | 5 | INHALED NICOTINE | PERFORMED | 3 | CARTRIDGE | CARTRIDGE | QD |
| RESPIRATORY (INHALATION) | PRODUCT EXPOSURE | 2004-07-07 | 2004-07-07 |
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The EX dataset shows the actual administrations. Note the scheduled records are not included. Only a few rows are shown for illustration. The pharmaceutical strength was included to identify the the dose of the nicotine inhaler used by the subject. Since EXENDTC is an expected variable, the sponsor populated this timing variable with the start date.
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