In this study, subjects were randomized to different flavors of nicotine lozenges. 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 per day every 2 hours, and during visit 4-6 subjects were to use 1 lozenge every 4- 8 hours. 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 on two other days.
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
Row
STUDYID
DOMAIN
USUBJID
SUSEQ
SUTRT
SUCAT
SUDOSE
SUDOSU
SUDOSFR
SUSTDTC
SUENDTC
1
TLXS111
SU
ABC-01001
1
CIGARETTE
TOBACCO
1
CIGARETTE
QD
2020-06-26
2020-06-26
2
TLXS111
SU
ABC-01001
2
CIGAR
TOBACCO
2
CIGAR
QD
2020-07-27
2020-07-27
3
TLXS111
SU
ABC-01001
3
CIGARETTE
TOBACCO
1
CIGARETTE
QD
2020-08-15
2020-07-15
4
TLXS111
SU
ABC-02001
1
BEER
ALOCHOL
24
OZ
QD
2021-09-15
2021-09-15
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.
su.xpt
cm.xpt
Row
STUDYID
DOMAIN
USUBJID
CMSEQ
CMTRT
CMMODIFY
CMCLAS
CMDOSE
CMDECOD
CMDOSU
CMDOSFRM
CMSTDTC
CMENDTC
1
TLXS111
SU
ABC-01007
1
Nicotine Replacement Patch
Nicotine
DRUGS USED IN NICOTINE DEPENDENCE
14
Nicotine
mg
PATCH
2020-06-26
2020-06-26
Dataset Debug Messages
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 2 bottles of lozenges that contained 40 lozenges each, The number of lozenges 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 dispensed amount of lozenges to the subject. In this example, the total number of lozenges dispensed were tracked, and not the bottles.
Rows 2 4
Shows the amount of lozenges 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
Row
STUDYID
DOMAIN
USUBJID
DASEQ
DATEST
DACAT
DASCAT
DAORRES
DAORRESU
DASTRESC
DASTRESN
DASTRESU
VISITNUM
DADTC
1
TLXS111
DA
ABC-01001
1
Dispensed Amount
STUDY PRODUCT
LOZENGE
80
LOZENGE
80
80
LOZENGE
1
2004-06-26
2
TLXS111
DA
ABC-01001
3
Returned Amount
STUDY PRODUCT
LOZENGE
24
LOZENGE
24
24
LOZENGE
2
2020-07-06
3
TLXS111
DA
ABC-01001
5
Dispensed Amount
STUDY PRODUCT
LOZENGE
80
LOZENGE
80
80
LOZENGE
2
2020-07-06
4
TLXS111
DA
ABC-01001
7
Returned Amount
STUDY PRODUCT
LOZENGE
34
LOZENGE
34
34
LOZENGE
3
2020-07-14
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
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 per day every 2 hours, and during visit 4-6 subjects used 1 lozenge every 4- 8 hours. 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 lozenges. When this variable is used, it must be populated for all records. This variable can not be used in EX.
Row 1
Show the scheduled usage recommendation for the lozenge. 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 hours.
Rows 2, 3
Shows the actual "performed" amount of lozenges 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 lozenge. ECDOSRGM shows that for these start and end dates the subject was recommended to use 1 lozenges every 4-8 hours.
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
Row
STUDYID
DOMAIN
USUBJID
ECSEQ
ECTRT
ECMOOD
ECDOS
ECDOSU
ECDOSFREQ
ECDOSRGM
ECROUTE
EPOCH
ECSTDTC
ECENDTC
1
TLXS111
EC
TLX701
Nicotine Lozenge
SCHEDULED
1
Lozenge
Every 1-2 hours
ORAL
TREATMENT
2004-06-26
2004-7-31
2
TLXS111
EC
TLX701
Nicotine Lozenge
PERFORMED
7
Lozenge
ORAL
TREATMENT
2004-06-26
3
TLXS111
EC
TLX701
Nicotine Lozenge
PERFORMED
2
Lozenge
ORAL
TREATMENT
2004-06-27
4
TLXS111
EC
TLX2001
Nicotine Lozenge
SCHEDULED
1
Lozenge
Every 4-8 hours
ORAL
TREATMENT
2004-08-20
2004-09-14
5
TLXS111
EC
TLX1001
Nicotine Lozenge
PERFORMED
3
Lozenge
ORAL
TREATMENT
Dataset Debug Message
There are ten leading, trailing, or non-breaking spaces in the dataset.
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.