Phototherapy Administration

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.

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.

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

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EXDOSFRQ

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

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

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