Pancreatic Cancer Stent Placement

Illustrates Domains

DI
DX

Illustrates Variables

SPDEVID
DXLOC
DXOCCUR

Content

The Device Identifiers (DI) domain is used to represent information about stents used in a study. In the DI domain, each unique set of identifying characteristics is associated with a unique SPDEVID value, which can then be used in other domains to reference the devices that are identified in the DI domain. The appropriate device was assigned for each prespecified or collected device. Note: When DIPARMCD ="DEVTYPE", DIVAL is assigned using Global Medical Device Nomenclature (GMDN) terminology. Example terms do not represent valid GMDN terms, which are copyrighted.

di.xpt

di.xpt

STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
PACA005	DI	STENT001	1	DEVTYPE	Device Type	Pancreatic stent
PACA005	DI	MSTENT001	2	DEVTYPE	Device Type	Bare-metal stent
PACA005	DI	BSTENT001	3	DEVTYPE	Device Type	Non-metal biliary stent
PACA005	DI	DSTENT001	4	DEVTYPE	Device Type	Duodenal stent

Stent exposure is represented in the Device Exposure (DX) domain. The DXTRT variable represents the name of the device to which subjects were exposed; the value of the SPDEVID variable indicates that each record specifically relates to the stent devices identified in the DI domain.

dx.xpt

Row 1:	Shows that subject 501 had a stent inserted before the study. DXDTC is the date the data was collected, which was assigned by the sponsor as the visit 1 date. Note that SPDEVID and DXLOC are null as this observation is not related to a specific stent.
Row 2:	Shows that subject 501 still had a stent in place in the bile duct at the start of the study, and it remained in place throughout the study. Note that DXSTRTPT was assigned "BEFORE" and DXENRTPT was assigned "ONGOING". DXSTTPT was assigned the timing descriptor of "VISIT 1" and DXENTPT was assigned the timing description of the subject's last visit. SPDEVID is included to identify the device used.
Row 3:	Shows that subject 502 did not have any stent insertions prior to the start of the study (SPDEVID is null).
Rows 4-5:	Show that subject 502 had a stent inserted into the duodenal duct during the study. This stent was removed and then replaced. This stent was still in place at the end of the study.

dx.xpt

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	DXSEQ	DXTRT	DXPRESP	DXOCCUR	DXLOC	DXDTC	DXSTDTC	DXENDTC	DXEVINTX	DXSTRTPT	DXSTTPT	DXENRTPT	DXENTPT
1	PACA005	DX	501		1	STENT	Y	Y		2019-11-01			LIFETIME
2	PACA005	DX	501	STENT001	2	STENT			BILE DUCT					BEFORE	VISIT 1	ONGOING	VISIT 10
3	PACA005	DX	502		1	STENT	Y	N		2019-11-01			LIFETIME
4	PACA005	DX	502	DSTENT001	2	STENT	Y		DUODENAL DUCT		2020-04-17	2020-06-01
5	PACA005	DX	502	DSTENT001	3	STENT	Y		DUODENAL DUCT		2020-06-01					ONGOING	VISIT 10