2 results
Approved WMOCompleted
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…
Approved WMOCompleted
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…