You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 8 Next »

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 1Shows the cigarettes used for the day of assessment. SUDOSFRQ was represented using the controlled terminology for per day, QD.
Rows 2-3Show 2 other records for a subject's usage of tobacco products on two other days.
Row 4Shows the subjects use of alcohol. Note, the sponsor collected the ounces of the product used using a pre-specified amount per drink.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

su.xpt

xx.xpt

RowSTUDYIDDOMAINUSUBJIDSUSEQSUTRTSUCATSUDOSESUDOSU

SUDOSFR

SUSTDTCSUENDTC
1TLXS111SUABC-010011CIGARETTETOBACCO1CIGARETTE

QD


2020-06-262020-06-26
2TLXS111SUABC-010012CIGARTOBACCO2CIGARQD2020-07-272020-07-27
3TLXS111SUABC-010013CIGARETTETOBACCO1CIGARETTEQD2020-08-152020-07-15
4TLXS111SUABC-020011BEERALCOHOL 24OZQD2021-09-152021-09-15

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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
1TLXS111CMABC-010071Nicotine Replacement Patch  Nicotine DRUGS USED IN  NICOTINE DEPENDENCE14Nicotinemg

PATCH

2020-06-262020-06-26

Dataset Debug Message

There are four leading, trailing, or non-breaking spaces in the dataset.

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

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

da.xpt

da.xpt

RowSTUDYIDDOMAINUSUBJIDDASEQDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1TLXS111DAABC-01001

1

Dispensed AmountSTUDY PRODUCT90CARTRIDGE6060CARTRIDGE12004-06-26
2TLXS111DAABC-01001

2

Returned AmountSTUDY PRODUCT13CARTRIDGE2424CARTRIDGE22020-07-06
3TLXS111DAABC-01001

3

Dispensed AmountSTUDY PRODUCT90CARTRIDGE8080CARTRIDGE22020-07-06
4TLXS111DAABC-01001

4

Returned AmountSTUDY PRODUCT10CARTRIDGE3434CARTRIDGE32020-07-14

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The recommended usage instruction for the lozenge 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 1Show 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, 3Shows 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 4Show 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 5Shows 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 Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

ec.xpt

ec.xpt

RowSTUDYIDDOMAINUSUBJIDECSEQECTRTECMOODECDOSECDOSUECDOSFREQECDOSRGM ECROUTEEPOCHECSTDTCECENDTC
1TLXS111ECTLX7011Nicotine Lozenge  SCHEDULED1 CARTRIDGE
 6 -10 cartridges per dayRESPIRATORY (INHALATION)TREATMENT2004-06-262004-7-31
2TLXS111ECTLX7012Nicotine Lozenge  PERFORMED7CARTRIDGEQD
IRESPIRATORY (INHALATION)TREATMENT2004-06-262004-06-26
3TLXS111ECTLX7013Nicotine Lozenge  PERFORMED2CARTRIDGE

IRESPIRATORY (INHALATION)TREATMENT2004-06-272004-06-27
4TLXS111ECTLX7014Nicotine Lozenge  SCHEDULED1CARTRIDGE
3-6 cartridges per dayRESPIRATORY (INHALATION)L TREATMENT2004-08-202004-09-14
5TLXS111ECTLX7015Nicotine Lozenge  PERFORMED3CARTRIDGEQD
RESPIRATORY (INHALATION)TREATMENT2004-08-202004-08-20

Dataset Debug Messages

  • There are nine leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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

RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXDOSEEXDOSUEXDOSFRQEXROUTEECPSTRGECPSTRGUEPOCHEXSTDTCEXENDTC
1ABCEXABC10011INHALED NICOTINE   13CARTRIDGEQDRESPIRATORY (INHALATION)6mgTREATMENT2004-06-262004-06-26
2ABCEXABC20012INHALED NICOTINE   5CARTRIDGEQDRESPIRATORY (INHALATION)6mgTREATMENT2011-06-272011-06-27
3ABCEXABC20021INHALED NICOTINE     6CARTRIDGEQDRESPIRATORY (INHALATION)4mgTREATMENT2011-08-282011-08-28
4ABCEXABC20022INHALED NICOTINE  17CARTRIDGEQDRESPIRATORY (INHALATION)4mgTREATMENT2011-08-292011-08-29

Dataset Debug Messages

  • There are nine leading, trailing, or non-breaking spaces in the dataset.
  • Please remove all formatting (see How to Clear Formatting).
  • No labels