EX/EC Example 2

In this study, subjects were randomized to one of three nicotine dosage levels. At the baseline visit (Week 0), they receiving an ENDS device that used 0, 8 or 24 mg/ml nicotine liquid. Self-reported daily cigarette consumption were recorded for each day of the study for 4 weeks. The subjects were supplied replacement nicotine cartridges at each weekly visit. The sponsor used an electronic diary application to track when the cartridge were replaced, and the daily number of cigarettes smoked. The subject used their normal brand cigarettes, and these were not supplied by the sponsor, and not considered a study product. Each cartridge was 8 mL. No other Nicotine replacement products were allowed to be used. Multiple cartridges were dispensed at a visit.

The sponsor reported the cigarettes used in the in the SU domain. The number of cigarettes smoked for each day of the study after the first visit were represented. If no cigarettes were smoked, a 0 was recorded. Only a few rows are shown.

su.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC
1	TENDS01	SU	ABC-01001	1	CIGARETTES	TOBACCO	6	CIGARETTE	PER DAY	2020-06-27	2020-06-27
2	TENDS01	SU	ABC-01001	1	CIGARETTES	TOBACCO	1	CIGARETTE	PER DAY	2020-06-28	2020-06-28
3	TENDS01	SU	ABC-01001	1	CIGARETTES	TOBACCO	0	CIGARETTE	PER DAY	2020-06-29	2020-06-29

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A Product Accountability domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. This unique number was represented in DAREF. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed. Cartridges were replaced at each visit. DADTC are the visit dates when the cartridge was returned or dispensed. Cartridges not used were record as having the full volume returned.

da.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	DASEQ	DAREFID	DATESTCD	DATEST	DACAT	DAORRES	DAORRESU	DASTRESC	DASTRESN	DASTRESU	VISITNUM	DADTC
1	ABC	DA	ABC-01001	1	CRT8754	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	1	2004-06-26
2	ABC	DA	ABC-01001	2	CRT8768	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	1	2004-06-26
3	ABC	DA	ABC-01001	3	CRT8769	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	1	2004-06-26
4	ABC	DA	ABC-01001	4	CRT8754	RETAMT	Returned Amount	STUDY PRODUCT	2	mL	6	6	mL	2	2020-07-06
2	ABC	DA	ABC-01001	5	CRT8768	RETAMT	Returned Amount	STUDY PRODUCT	1.6	mL	8	8	mL	2	2020-07-06
3	ABC	DA	ABC-01001	6	CRT8769	RETAMT	Returned Amount	STUDY PRODUCT	8	mL	8	8	mL	2	2020-07-06
5	ABC	DA	ABC-01001	7	CRT9756	DISPAMT	Dispensed Amount	STUDY PRODUCT	8	mL	8	8	mL	2	2020-07-06
6	ABC	DA	ABC-01001	8	CRT9756	RETAMT	Returned Amount	STUDY PRODUCT	1.0	mL	1.3	1.3	mL	3	2020-07-10

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.

The domain represented the number of cartridges used (in this example always 1 since each cartridge was tracked), the total amount amount of liquid product used determined from the DA domain and the associated nicotine pharmaceutical strength of each cartridge. The sponsored used this information in the analysis. The summaries included in the analysis were the estimated number of cartridges used per week, and the estimated nicotine exposer from the cartridges per day.

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ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXREFID	EXTRT	EXDOSE	EXDOSU	EXROUTE	EXPSTRG	EXPSTRG	EXSTDTC	EXENDTC
1	TENDS01	EX	10001	1	CRT8754	e-nicotine liquid	6	mL	INHALED	8	mg/mL	2020-06-26	2020-07-01
2	TENDS01	EC	10001	2	CRT8768	e-nicotine liquid	6.7	mL	INHALED	8	mg/mL	2020-07-01	2020-07-06
3	TENDS01	EC	10001	3	CRT9756	e-nicotine liquid	7	mL	INHALED	8	mg/mL	2020-07-06	2020-07-10
3	TENDS01	EC	10001	4	CRT9778	e-nicotine liquid	8	mL	INHALED	8	mg/mL	2020-07-10	2020-07-14
4	TENDS01	EC	10002	1	CRT8000	e-nicotine liquid	5	mL	INHALED	24	mg/mL	2020-09-01	2020-09-07
5	TENDS01	EC	10002	2	CRT9006	e-nicotine liquid	7	mL	INHALED	24	mg/mL	2020-09-07	2020-09-14
6	TENDS01	EC	10002	3	CRT9008	e-nicotine liquid	8	mL	INHALED	24	mg/mL	2020-09-14	2020-09-21
7	TENDS01	EC	10002	4	CRT9017	e-nicotine liquid	6	mL	INHALED	24	mg/mL	2020-09-21	2020-09-28
8	TENDS01	EC	10002	5	CRT9089	e-nicotine liquid	7	mL	INHALED	24	mg/mL	2020-09-28	2020-09-31
9	TENDS01	EC	10002	6	CRT9128	e-nicotine liquid	8	mL	INHALED	24	mg/mL	2020-10-31	2020-10-08
10	TENDS01	EC	10002	7	CRT6868	e-nicotine liquid	6.7	mL	INHALED	24	mg/mL	2020-10-08	2020-10-15
11	TENDS01	EC	10002	8	CRT7868	e-nicotine liquid	5.5	mL	INHALED	24	mg/mL	2020-10-15	2020-10-22

Dataset Debug Messages

There are 11 leading, trailing, or non-breaking spaces in the dataset.
There seem to be multiple domains (EX, EC) present in the dataset.
There is a duplicate variable (EXPSTRG) in the dataset.

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EX/EC Example 2