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In this study, subjects were randomized to different doses of a nicotine inhaler. The recommended usage instruction for the nicotine inhaler 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. Subject 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 product used each day. Only days were a product was 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.   

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.

su.xpt

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RowSTUDYIDDOMAINUSUBJIDSUSEQSUTRTSUCATSUDOSESUDOSU

SUDOSFR

SUSTDTCSUENDTC
1TIN111SUTIN7011CIGARETTETOBACCO1CIGARETTE

QD

2020-06-262020-06-26
2TIN111SUTIN7012CIGARTOBACCO2CIGARQD2020-07-272020-07-27
3TIN111SUTIN8011CIGARETTETOBACCO1CIGARETTEQD2020-07-152020-07-15
4TIN111SUTIN8012BEERALCOHOL24OZQD2020-07-202020-07-20
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Dataset Wrapper Debug Message

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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.  

cm.xpt

cm.xpt

RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMMODIFYCMCLASCMDOSECMDECODCMDOSU

CMDOSFRM

CMSTDTCCMENDTC
1TIN111CMTIN7011Nicotine Replacement PatchNicotineDRUGS USED IN NICOTINE DEPENDENCE14Nicotinemg

PATCH

2020-06-262020-06-27
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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 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. DASPID 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 returned, these corresponded to the dates of the visits.   

Rows 1, 3:Show the number of cartridges dispensed to the subject.
Rows 2, 4:Show the number of cartridges returned by the subject.

da.xpt

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TIN111DATIN701

1

Dispensed AmountSTUDY PRODUCT90CARTRIDGE6060CARTRIDGE12004-06-26
2TIN111DATIN701

2

Returned AmountSTUDY PRODUCT13CARTRIDGE2424CARTRIDGE22020-07-06
3TIN111DATIN701

3

Dispensed AmountSTUDY PRODUCT90CARTRIDGE8080CARTRIDGE22020-07-06
4TIN111DATIN701

4

Returned AmountSTUDY PRODUCT10CARTRIDGE3434CARTRIDGE32020-07-14
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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 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 inhaled nicotine. When this variable is used, it must be populated for all records. This variable can not be used in EX.  

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 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.

ec.xpt

ec.xpt

RowSTUDYIDDOMAINUSUBJIDECSEQECTRTECMOODECDOSECDOSUECDOSFREQECDOSRGMECROUTEEPOCHECSTDTCECENDTC
1TIN111ECTIN7011INHALED NICOTINESCHEDULED
CARTRIDGE
6 -10 cartridges per dayRESPIRATORY (INHALATION)TREATMENT2004-06-262004-07-06
2TIN111ECTIN7012INHALED NICOTINEPERFORMED7CARTRIDGEQD
IRESPIRATORY (INHALATION)TREATMENT2004-06-262004-06-26
3TIN111ECTIN7013INHALED NICOTINEPERFORMED2CARTRIDGEQD
IRESPIRATORY (INHALATION)TREATMENT2004-06-272004-06-27
4TIN111ECTIN7014INHALED NICOTINESCHEDULED
CARTRIDGE
3-6 cartridges per dayRESPIRATORY (INHALATION)TREATMENT2004-07-062004-07-20
5TIN111ECTIN7015INHALED NICOTINEPERFORMED3CARTRIDGEQD
RESPIRATORY (INHALATION)TREATMENT2004-07-072004-07-07
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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 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.    

  

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXROUTEEXPSTRGEXPSTRGUEPOCHEXSTDTCEXENDTC
1TIN111EXTIN7011INHALED NICOTINE7CARTRIDGERESPIRATORY (INHALATION)6mgTREATMENT2004-06-262004-06-26
2TIN111EXTIN7012INHALED NICOTINE2CARTRIDGERESPIRATORY (INHALATION)6mgTREATMENT2004-06-272004-06-27
3TIN111EXTIN7011INHALED NICOTINE3CARTRIDGERESPIRATORY (INHALATION)4mgTREATMENT2004-07-072004-07-07
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