2 results
Approved WMOCompleted
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
Approved WMOCompleted
To evaluate the safety and efficacy of a single oral dose of vanoxerine for the conversion of subjects with recent atrial fibrillation (AF) or atrial flutter (AFL) to normal sinus rhythm.