4 results
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Evaluation of the pharmacodynamic and pharmacokinetic effects of multiple doses of ACT-078573 on the pharmacokinetics of a single dose of desipramine
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…
This pilot does not aim to demonstrate the effectiveness of the system. The effectiveness of the system has been demonstrated in the recently published study: Chromed study, a multi-center Randomized Controlled Study.This pilot aims to obtain…