2 results
Approved WMOCompleted
(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…
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…