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.
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.
|1||PSRS-02||EX||PSRS-201||1||PUVA1||UVA||PHOTOTHERAPY||PUVA||50||J/cm2||2 TIMES PER WEEK||TREATMENT||2014-02-01||2015-03-15|
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.
|1||PSRS-02||AG||PSRS-201||1||PUVA1||Psoralen||PHOTOSENSITIZING AGENT||PUVA||40||mg||TABLET||2 TIMES PER WEEK||ORAL||TREATMENT||2014-02-01||2014-03-15||-PT90M||PHOTOTHERAPY ADMINISTRATION|
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.
|1||PSRS-03||EX||PSRS-301||LB03||1||UVB||PHOTOTHERAPY||0.155||J/cm2||2 TIMES PER WEEK||TREATMENT||2016-07-01||2016-08-15|
Identifying information about the light box from the preceding EX dataset is shown using the DI domain.
|Rows 1-3:||Show the device type, manufacturer, and model number of the UVB light box, identified by SPDEVID=LB03.|
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.
|1||PSRS-03||DI||LB03||1||DEVTYPE||Device Type||UVB Light Box|
|4||PSRS-03||DI||LB-B1||1||DEVTYPE||Device Type||UV Bulb|
Properties of the light box which do not change during the course of the study are represented in the Device Properties (DO) domain.
|1||PSRS-03||LB03||1||BULBNUM||Number of Bulbs||6|
The relationship between a device and its components (in this case, a light box and its bulbs) is represented in the RELDEV dataset.
|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).|
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.