Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.
Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
Japan: Pharmaceuticals and Medical Devices Agency