In this study, subjects were randomized to different flavors doses of a nicotine lozengesinhaler. The recommended usage instruction for the lozenge nicotine inhaler were provided to the subject at each visit. At visit 1-3 subjects were to use 1 lozenges 6-10 cartridges per day every 2 hours, and during visit 4-6 subjects were to use 1 lozenge every 4- 8 hours. 3-6 cartridges per day. Subject were encouraged to not to use any other tobacco products, nicotine replacement therapies 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 product used each day. Only days were a product was used used were represented.
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 | 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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Dataset2 |
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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 | ALOCHOL ALCOHOL | 24 | OZ | QD | 2021-09-15 | 2021-09-15 |
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Drugs used in nicotine dependency are considered 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 | TLXS111 | SUCM | ABC-01007 | 1 | Nicotine Replacement Patch | Nicotine | DRUGS USED IN NICOTINE DEPENDENCE | 14 | Nicotine | mg | PATCH
| 2020-06-26 | 2020-06-26 |
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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 2 bottles of lozenges that contained 40 lozenges each, The number of lozenges returned 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. DDASPID 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 or returned, these corresponded to the dates of the visits.
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Rows 1,3 | Show the dispensed amount of lozenges number of cartridges dispensed to the subject. In this example, the total number of lozenges dispensed were tracked, and not the bottles. | Rows 2 4 | Shows the amount number of lozenges cartridges returned by the subject. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | DASEQ | DATEST | DACAT |
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DASCAT | DAORRES | DAORRESU | DASTRESC | DASTRESN | DASTRESU | VISITNUM | DADTC |
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1 | TLXS111 | DA | ABC-01001 | | Dispensed Amount | STUDY PRODUCT | LOZENGE80LOZENGE8080 | LOZENGECARTRIDGE | 1 | 2004-06-26 | 2 | TLXS111 | DA | ABC-01001 | 3 | Returned Amount | STUDY PRODUCT | LOZENGE24LOZENGE | LOZENGECARTRIDGE | 2 | 2020-07-06 | 3 | TLXS111 | DA | ABC-01001 | 5 | Dispensed Amount | STUDY PRODUCT | LOZENGE80 | LOZENGELOZENGECARTRIDGE | 2 | 2020-07-06 | 4 | TLXS111 | DA | ABC-01001 | 7 | Returned Amount | STUDY PRODUCT | LOZENGE34 | LOZENGELOZENGE |
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The sponsor the recommended usage instruction for the lozenge were provided to the subject at each visit. At visit 1-3 subjects were to use 1 lozenges 6 -10 cartridges per day every 2 hours, and during visit 4-6 subjects used 1 lozenge every 4- 8 hours. The 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 permissible; variable was used to reflect the intended usage recommendations and the actual usage of the lozengesinhaled 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 | Show the scheduled usage recommendation for the lozengeinhaled 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 the lozenges every 1- 2 hours6-12 cartridges every day. | Rows 2, 3 | Shows the actual "performed" amount of lozenges inhaled nicotine used by the subject each day. Note only a few rows of the performed records are shown. | Row 4 | Show the scheduled usage recommendation for the lozengeinhaled nicotine. ECDOSRGM ECDOSRGM shows that for these start and end dates the subject was recommended to use 1 lozenges every 4-8 hours3-6 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 | TLXS111 | EC | TLX701 | 1 | Nicotine Lozenge | SCHEDULED | 1 | LozengeCARTRIDGE | Every 1-2 hours |
| 6 -10 cartridges per day | RESPIRATORY (INHALATION)ORAL | TREATMENT | 2004-06-26 | 2004-7-31 | 2 | TLXS111 | EC | TLX701 | 2 | Nicotine Lozenge | PERFORMED | 7 | LozengeCARTRIDGE | QDORAL |
| IRESPIRATORY (INHALATION) | TREATMENT | 2004-06-26 | 2004-06-26 | 3 | TLXS111 | EC | TLX701 | 3 | Nicotine Lozenge | PERFORMED | 2 | Lozenge | CARTRIDGE |
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| IRESPIRATORY (INHALATION)ORAL | TREATMENT | 2004-06-27 | 2004-06-27 | 4 | TLXS111 | EC | TLX2001TLX701 | 4 | Nicotine Lozenge | SCHEDULED | 1 | LozengeCARTRIDGE | Every 4-8 hours |
| 3-6 cartridges per day | RESPIRATORY (INHALATION)L ORAL | TREATMENT | 2004-08-20 | 2004-09-14 | 5 | TLXS111 | EC | TLX1001TLX701 | 5 | Nicotine Lozenge | PERFORMED | 3 | LozengeCARTRIDGE | QDORAL |
| RESPIRATORY (INHALATION) | TREATMENT | 2004-08-20 | 2004-08-20 |
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The EX dataset shows the actual administrations. Note 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.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | EXSEQ | EXTRT | EXDOSE | EXDOSU | EXDOSFRQ | EXROUTE | ECPSTRG | ECPSTRGU | EPOCH | EXSTDTC | EXENDTC |
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1 | ABC | EX | ABC1001 | 1 | Lozenge Cherry Flavor | 7 | INHALED NICOTINE | 13 | CARTRIDGELOZENGE | QD | RESPIRATORY (INHALATION) | 6 | mgORAL | TREATMENT | 2004-06-26 | 2004-06-26 | 2 | ABC | EX | ABC2001 | 2 | Lozenge Cherry Flavor INHALED NICOTINE | 5 | LOZENGECARTRIDGE | QD | RESPIRATORY (INHALATION) | 6 | mgORAL | TREATMENT | 2011-06-27 | 2011-06-27 | 3 | ABC | EX | ABC2002 | 1Lozenge Mint Flavor | INHALED NICOTINE | 6 | LOZENGECARTRIDGE | QD | RESPIRATORY (INHALATION) | 4 | mgORAL | TREATMENT | 2011-08-28 | 2011-08-28 | 4 | ABC | EX | ABC2002 | 2Lozenge | Mint Flavor INHALED NICOTINE | 17 | LOZENGECARTRIDGE | QD | RESPIRATORY (INHALATION) | 4 | mgORAL | TREATMENT | 2011-08-29 | 2011-08-29 |
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