Treatment Dispensed and Returned - Combination Drug

Illustrates Domains

DA
EC
EX
RELREC

Illustrates Variables

DAGRPID
DASPID
DACAT
DASCAT
EPOCH
ECSPID
ECNMDOSE
EXGRPID
EXSPID
EXNMDOSE

Content

This example shows the administration of a cream with a combination of drugs (X and Y) compared to a cream with a single drug (Y only). Subjects were instructed to apply the cream once daily. Each subject was given an identical 130 g single tube of medication to use between study visits. A new tube was dispensed at each visit and the previously dispensed tube was returned. The returned tubes were weighed and these values were recorded.

The sponsor chose to add EPOCH and to use DASPID to identify each tube dispensed and returned.

da.xpt

Row 1:	Shows that at the first visit on day 1, a tube of study product weighing 130 g was dispensed to the subject.
Row 2:	Shows that at the second visit on day 15, a tube of study product weighing 10 g was returned by the subject.
Rows 3-4:	Show that at visit 2, another 130 g tube was dispensed; this tube was returned at visit 3 weighing 30 g.

da.xpt

Row	STUDYID	DOMAIN	USUBJID	DASEQ	DAGRPID	DASPID	DATESTCD	DATEST	DACAT	DASCAT	DAORRES	DAORRESU	DASTRESC	DASTRESN	DASTRESU	VISITNUM	EPOCH	DADTC	DADY
1	PS014	DA	101	1	1	A311	DISPAMT	Dispensed Amount	Study Product Weight	Tube A	130	g	130	130	g	1	Study Period 1	2012-05-01	1
2	PS014	DA	101	2	1	A311	RETAMT	Returned Amount	Study Product Weight	Tube A	10	g	10	10	g	2	Study Period 1	2012-05-15	15
3	PS014	DA	101	3	1	A312	DISPAMT	Dispensed Amount	Study Product Weight	Tube A	130	g	130	130	g	2	Study Period 1	2012-05-15	15
4	PS014	DA	101	4	1	A312	RETAMT	Returned Amount	Study Product Weight	Tube A	30	g	30	30	g	3	Study Period 1	2012-05-30	30

The sponsor collected the dates when the subject started and ended using each tube, and the number of missed doses during this interval. The number of missed doses was represented in NSEC.ECNMDOSE and ECDOSE was used to show the number of applications per day.

ec.xpt

Row 1:	Shows the start and end dates for when the tube of medication labeled A311 was used. There was 1 missed dose in the interval.
Row 2:	Shows the start and end dates for when the tube of medication labeled A312 was used. There were 2 missed doses in the interval.

ec.xpt

Row	STUDYID	DOMAIN	USUBJID	ECSEQ	ECSPID	ECTRT	ECDOSE	ECDOSU	ECDOSFRM	ECDOSFRQ	ECSTDTC	ECENDTC	ECSTDY	ECENDY		ECNMDOSE
1	PS014	EC	101	1	A311	Study Drug	1	APPLICATION	CREAM	QD	2012-05-01	2012-05-15	1	15		1
2	PS014	EC	101	2	A312	Study Drug	1	APPLICATION	CREAM	QD	2012-05-16	2012-05-30	16	30		2

EC NSV Metadata

Variable	Label	Type	Role	Origin
ECNMDOSE	Number of Missed Doses	integer	Non-Standard Record Qualifier	CRF

The sponsor represented the exposure in the EX dataset as 1 record for each tube dispensed. EXDOSE shows the number of applications per day; it was not possible to derive an actual amount of drug used per application or per day. When the subject was randomized to the combination treatment, a record was included for each active component of the combination.

ex.xpt

Rows 1-2:	Show the dosage concentration used for each component of the combination product using EXPSTRG and EXPSTRGU. NSEX.EXNMDOSE indicates the number of missed doses in this interval. EXSPID indicates what tube was used for this dosing interval. EXSPID was used by the sponsor to link to actual weight of the product used in this interval represented in the DA dataset. EXDOSE is provided based on the number of applications.
Row 3:	Shows the dosage concentration used for the single product.

Rows 1-2:

Show the dosage concentration used for each component of the combination product using EXPSTRG and EXPSTRGU. NSEX.EXNMDOSE indicates the number of missed doses in this interval. EXSPID indicates what tube was used for this dosing interval. EXSPID was used by the sponsor to link to actual weight of the product used in this interval represented in the DA dataset. EXDOSE is provided based on the number of applications.

Row 3:

Shows the dosage concentration used for the single product.

ex.xpt

Row	STUDYID	DOMAIN	USUBJID	EXSEQ	EXGRPID	EXSPID	EXTRT	EXDOSE	EXDOSU	EXDOSFRM	EXDOSFRQ	EXPSTRG	EXPSTRGU	EPOCH	EXSTDTC	EXENDTC	EXSTDY	EXENDY	EXNMDOSE
1	PS014	EX	101	1	1	A311	Drug X	1	APPLICATION	CREAM	QD	50	ug/g	TREATMENT	2012-05-01	2012-05-15	1	15	1
2	PS014	EX	101	2	1	A311	Drug Y	1	APPLICATION	CREAM	QD	0.5	mg/g	TREATMENT	2012-05-01	2012-05-15	1	15	1
3	PS014	EX	101	3	2	A312	Drug Y	1	APPLICATION	CREAM	QD	0.5	mg/g	TREATMENT	2012-05-16	2012-05-30	16	30	2

EX NSV Metadata

Variable	Label	Type	Role	Origin
EXNMDOSE	Number of Missed Doses	integer	Non-standard Record Qualifier	CRF

This is an example of the relationships record between the SDTM domains. --SPID was used to link the relevant datasets.

relrec.xpt

relrec.xpt

Row	STUDYID	RDOMAIN	IDVAR	RELTYPE	RELID
1	PS014	DA	DASPID	MANY	1
2	PS014	EX	EXSPID	MANY	1
3	PS014	EC	ECSPID	MANY	1