Special Drug Use-results Survey of Targretin Capsules combined with photo(chemo)therapy

JRCT ID: jRCT2031210625

Registered date:23/02/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Cutaneous T-cell lymphoma
• Date of first enrollment: 01/02/2022
• Target sample size: 70
• Study type: Observational

Outcome(s)

• Primary Outcome: Incidence of photosensitivity and similar skin adverse events and their 95% confidence intervals

Secondary Outcome

The incidence of adverse events by System Organ Class(SOC) and Preferred Term(PT) using MedDRA / J and its 95% confidence interval
Response rate (CR + PR) and its confidence interval based on the best overall effect of mSWAT.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Cases in which UV therapy is being performed and the combined use of bexarotene and UV therapy is started during the registration period.
However, if bexarotene has been used, cases that have not been administered for more than 4 weeks since the last administration
(2) Cases registered for the first time in this survey
(3) Patients who have been treated with UV therapy at a standard frequency (at least once a week) for about one month before the start of concomitant use with bexarotene, and the status of the treatment can be confirmed.
(4) Cases in which the consent of the patient was obtained

• Exclude criteria: adult T-cell leukemia/lymphoma

Related Information

• Primary Sponsor: pharmacovigilance departmant