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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 subjects 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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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SUSEQ | SUTRT | SUCAT | SUDOSE | SUDOSU | SUDOSFR | SUSTDTC | SUENDTC |
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| 1 | TLXS111TIN111 | SU | ABC-01001TIN701 | 1 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-06-26 | 2020-06-26 |
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| 2 | TLXS111TIN111 | SU | ABC-01001TIN701 | 2 | CIGAR | TOBACCO | 2 | CIGAR | QD | 2020-07-27 | 2020-07-27 |
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| 3 | TLXS111TIN111 | SU | ABC-01001TIN801 | 31 | CIGARETTE | TOBACCO | 1 | CIGARETTE | QD | 2020-0807-15 | 2020-07-15 |
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| 4 | TLXS111TIN111 | SU | ABC-02001TIN801 | 12 | BEER | ALCOHOL | 24 | OZ | QD | 20212020-0907-15202021 | 2020-0907-1520 |
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Drugs used in 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 CMCLA, CMDECOD, and CM MODIFY. 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 | CMCLAS | CMDOSE | CMDECOD | CMDOSU | CMDOSFRM | CMSTDTC | CMENDTC |
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| 1 | TLXS111TIN111 | CM | ABC-01007TIN701 | 1 | Nicotine Replacement Patch | Nicotine | DRUGS USED IN NICOTINE DEPENDENCE | 14 | Nicotine | mg | PATCH | 2020-06-26 | 2020-06-27 |
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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 | DATEST | DACAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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| 1 | TLXS111TIN111 | DA | ABC-01001TIN701 | | Dispensed Amount | STUDY PRODUCT | 90 | CARTRIDGE | 60 | 60 | CARTRIDGE | 1 | 2004-06-26 | | 2 | TLXS111TIN111 | DA | ABC-01001TIN701 | | Returned Amount | STUDY PRODUCT | 13 | CARTRIDGE | 24 | 24 | CARTRIDGE | 2 | 2020-07-06 | | 3 | TLXS111TIN111 | DA | ABC-01001TIN701 | | Dispensed Amount | STUDY PRODUCT | 90 | CARTRIDGE | 80 | 80 | CARTRIDGE | 2 | 2020-07-06 | | 4 | TLXS111TIN111 | DA | ABC-01001TIN701 | | Returned Amount | STUDY PRODUCT | 10 | CARTRIDGE | 34 | 34 | CARTRIDGE | 3 | 2020-07-14 |
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The recommended usage instruction for the lozenge 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 DOSRGM, which is the intended Dose Regimen.
The ECMOOD ECMOOD permissible ; variable was used to reflect the intended usage recommendations 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 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 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 | ECDOSFREQ | ECDOSRGM | ECROUTE | EPOCH | ECSTDTC | ECENDTC |
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| 1 | TLXS111TIN111 | EC | TLX701TIN701 | 1 | INHALED NICOTINE | SCHEDULED | 1 |
| CARTRIDGE |
| 6 -10 cartridges per day | RESPIRATORY (INHALATION) | TREATMENT | 2004-06-26 | 2004-07-3106 | | 2 | TLXS111TIN111 | EC | TLX701TIN701 | 2 | INHALED NICOTINE | PERFORMED | 7 | CARTRIDGE | QD |
| IRESPIRATORY (INHALATION) | TREATMENT | 2004-06-26 | 2004-06-26 | | 3 | TLXS111TIN111 | EC | TLX701TIN701 | 3 | INHALED NICOTINE | PERFORMED | 2 | CARTRIDGE | QD |
| IRESPIRATORY (INHALATION) | TREATMENT | 2004-06-27 | 2004-06-27 | | 4 | TLXS111TIN111 | EC | TLX701TIN701 | 4 | INHALED NICOTINE | SCHEDULED | 1 |
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| 3-6 cartridges per day | RESPIRATORY (INHALATION) | TREATMENT | 2004-0807-2006 | 2004-0907-1420 | | 5 | TLXS111TIN111 | EC | TLX701TIN701 | 5 | INHALED NICOTINE | PERFORMED | 3 | CARTRIDGE | QD |
| RESPIRATORY (INHALATION) | TREATMENT | 2004-0807-2007 | 2004-0807-2007 |
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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 what dose of the nicotine inhaler was used by the subject. Since EXENDTC is an expected variable, the sponsor populated this timing variable with the start date.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXROUTE | EXPSTRG | EXPSTRGU | EPOCH | EXSTDTC | EXENDTC |
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| 1 | TLXS111TIN111 | EX | TLX701TIN701 | 1 | INHALED NICOTINE | 7 | CARTRIDGE | RESPIRATORY (INHALATION) | 6 | mg | TREATMENT | 2004-06-26 | 2004-06-26 | | 2 | TLXS111TIN111 | EX | TLX701TIN701 | 2 | INHALED NICOTINE | 2 | CARTRIDGE | RESPIRATORY (INHALATION) | 6 | mg | TREATMENT | 20112004-06-272011 | 2004-06-27 | | 3 | TLXS111TIN111 | EX | TLX701TIN701 | 1 | INHALED NICOTINE | 3 | CARTRIDGE | RESPIRATORY (INHALATION) | 4 | mg | TREATMENT | 20112004-0807-28072011 | 2004-0807-2807 |
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