In this study, subjects were randomized to different doses of a nicotine inhaler. The recommended usage instructions for the nicotine inhaler was were provided to the subject at each visit. At visit visits 1-3, subjects were to use 6-10 cartridges per day, and during visit visits 4-6 subjects were to use 3-6 cartridges per day. Subjects were encouraged 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 subjects provided information on the products used each day. Only days where a product was used were represented.
Alcohol usage and tobacco product usage were represented in the Substance Use (SU) domain. SUCAT allows the records to be grouped into tobacco-related data and alcohol-related data. In this example, the products were prespecified so SUTRT does not require a standardized SUDECOD equivalent. The sponsor applicant only includes SUSTDTC and SUENDTC as timing variables.
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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 2 other days. | | Row 4: | Shows the subject's use of alcohol. Note, the sponsor : The applicant collected the ounces of the product used using a pre-specified a prespecified 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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Drugs used to treat nicotine dependency are considered drugs and were represented in the Concomitant Medication (CM) domain. This subject used a 14 mg nicotine replacement patch. The sponsor applicant included the CMCLASS, CMDECOD, and CMMODIFY. 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 | CMDOSE | CMDOSU | CMDOSFRM | CMSTDTC | CMENDTC |
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| 1 | TIN111 | CM | TIN701 | 1 | Nicotine Replacement Patch | Nicotine | NICOTINE | DRUGS USED IN NICOTINE DEPENDENCE | 14 | mg | PATCH | 2020-06-26 | 2020-06-27 |
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A The 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 applicant 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 | 609060 | 90 | CARTRIDGE | 1 | 2004-06-26 | | 2 | TIN111 | DA | TIN701 | | RETAMT | Returned Amount | STUDY PRODUCT | 13 | CARTRIDGE | 241324 | 13 | CARTRIDGE | 2 | 2020-07-06 | | 3 | TIN111 | DA | TIN701 | | DISPAMT | Dispensed Amount | STUDY PRODUCT | 9050 | CARTRIDGE | 805080 | 50 | CARTRIDGE | 2 | 2020-07-06 | | 4 | TIN111 | DA | TIN701 | | RETAMT | Returned Amount | STUDY PRODUCT | 10 | CARTRIDGE | 341034 | 10 | CARTRIDGE | 3 | 2020-07-14 |
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The sponsor used the EC domain The applicant used a patient diary (not shown here) to determine how many cartridges the subject used on each day, then created the EC data to represent the collected exposure data. These usage Usage recommendations were represented in ECDOSRGM, which is the intended Dose Regimendose 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 : 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 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 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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The EX dataset shows the actual administrations. Note the scheduled Scheduled records are not included. Only , and only a few rows are shown for illustration purposes. The pharmaceutical strength was included to identify the dose of the nicotine inhaler used by the subject. Since EXENDTC Because EXENDTC is an expected variable, the sponsor applicant populated this timing variable with the start date.
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