Phototherapy Administration

Illustrates Domains

EX
AG
DI
DO
RELDEV

Illustrates Variables

EXTRT
EXCAT
EXSCAT
EXDOSFRQ
EPOCH
SPDEVID
AGDOSFRM
AGDOSFRQ
AGELTM
AGTPTREF
DIPARM
DIVAL
DOTESTCD
DOTEST
PARENT LEVEL


Content

The example datasets below show modeling for several instances of phototherapy. In these examples, the sponsor did not collect information on each phototherapy session.

The dataset for STUDYID PSRS-01 shows phototherapy data collected without the specifics of dosing. In the second row, PUVA is categorized as phototherapy.

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXLNKIDEXTRTEXCATEXSCATEXDOSEEXDOSUEXDOSFRQEPOCHEXSTDTCEXENDTC
1PSRS-01EXPSRS-1011
Phototherapy

PHOTOTHERAPY





TREATMENT2012-01-222012-02-05
2PSRS-01EXPSRS-1021
PUVAPHOTOTHERAPY



TREATMENT2012-01-252012-02-30

The dataset for STUDYID PSRS-02 shows the exposure to UV-A as part of a PUVA regimen. The record is subcategorized as PUVA under the category of PHOTOTHERAPY. This record is linked via EXLNKID to the psoralen exposure portion of the regimen in the Procedure Agents (AG) dataset. The dose units are represented as total energy per square centimeter of body surface.

ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDEXSEQEXLNKIDEXTRTEXCATEXSCATEXDOSEEXDOSUEXDOSFRQEPOCHEXSTDTCEXENDTC
1PSRS-02EXPSRS-2011PUVA1UVAPHOTOTHERAPYPUVA50J/cm22 TIMES PER WEEKTREATMENT2014-02-012015-03-15

The details about the psoralen administration are represented in the AG domain. The agent is not the drug under study, yet is necessary as part of the PUVA procedure. If psoralen (or any other photosensitizing agent) were the drug under study, it would be represented in the Exposure (EX) domain. The sponsor collected only limited details on timing of administration; AGELTM and AGTPTREF indicate that the psoralen was administered 90 minutes before phototherapy.

ag.xpt

ag.xpt

RowSTUDYIDDOMAINUSUBJIDSPDEVIDAGSEQAGLNKIDAGTRTAGCATAGSCATAGDOSEAGDOSUAGDOSFRMAGDOSFRQAGROUTEEPOCHAGSTDTCAGENDTCAGELTMAGTPTREF
1PSRS-02AGPSRS-201
1PUVA1PsoralenPHOTOSENSITIZING AGENTPUVA40mgTABLET2 TIMES PER WEEKORALTREATMENT2014-02-012014-03-15-PT90MPHOTOTHERAPY ADMINISTRATION
The dataset for STUDYID PSRS-03 

shows data representation for a subject who received UV-B therapy via a light box. 

In addition to the dose in J/cm

2

, the sponsor chose to collect the frequency of the treatment, as shown in

EXDOSFRQ

. In this example, the sponsor also chose to collect information about the light box used to produce the UV light. 
ex.xpt

ex.xpt

RowSTUDYIDDOMAINUSUBJIDSPDEVIDEXSEQEXLNKIDEXTRTEXCATEXSCATEXDOSEEXDOSUEXDOSFRQEPOCHEXSTDTCEXENDTC
1PSRS-03EXPSRS-301LB031
UVBPHOTOTHERAPY
0.155J/cm22 TIMES PER WEEKTREATMENT2016-07-012016-08-15

Identifying information about the light box from the preceding EX dataset is shown using the DI domain.

di.xpt
Rows 1-3:Show the device type, manufacturer, and model number of the UVB light box, identified by SPDEVID=LB03.
Rows 4-6:

Show the device type, manufacturer, and model number of the bulbs used in the light box. The relationship of these bulbs to the light box is made explicit in the RELDEV dataset.

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1PSRS-03DILB031DEVTYPEDevice TypeUVB Light Box
2PSRS-03DILB032MANUFManufacturerAcme
3PSRS-03DILB033MODELModelBoxLyte UV
4PSRS-03DILB-B11DEVTYPEDevice TypeUV Bulb
5PSRS-03DILB-B12MANUFManufacturerAcmeBrite
6PSRS-03DILB-B13MODELModelTUVL-311

Properties of the light box which do not change during the course of the study are represented in the Device Properties (DO) domain.

do.xpt

do.xpt

RowSTUDYIDSPDEVIDDOSEQDOTESTCDDOTESTDOORRESDOORRESU
1PSRS-03LB031BULBNUMNumber of Bulbs6
2PSRS-03LB-B12

WAVLNGTH

Wavelength311nm

The relationship between a device and its components (in this case, a light box and its bulbs) is represented in the RELDEV dataset.

reldev.xpt
Row 1:Shows the device, identified by SPDEVID=LB03 (a UV light box as described in the DI dataset), has no parent device, as indicated by LEVEL=1 (device level 1).
Row 2:

Shows the device, identified as LB-B1 (a bank of UV bulbs), is a component of parent device LB03 and is therefore a second-level device, as indicated by LEVEL=2.

reldev.xpt

RowSTUDYIDSPDEVIDPARENTLEVEL
1PSRS-03LB03
1
2PSRS-03LB-B1LB032