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.
|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.
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.
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).|
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.
|2||PACA005||DX||501||STENT001||2||STENT||BILE DUCT||BEFORE||VISIT 1||ONGOING||VISIT 10|
|5||PACA005||DX||502||DSTENT001||3||STENT||Y||DUODENAL DUCT||2020-06-01||ONGOING||VISIT 10|