4 results
Primary Objective:To assess the impact of TOOKAD® Soluble VTP on the rate of absence of definite cancer using patients onactive surveillance as a comparison (co-primary objective A).To determine the difference in risk of treatment failure associated…
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
The purpose of this study is to seek regulatory approval for use of fingolimod in a pediatric population with MS aged 10 to less than 18 years old. This study is conducted in line with the Pediatric Investigational Plan agreed with the EMA (under EU…
Objectives safety run-in: The primary objective is:• To assess the safety of i.v. teicoplanin prophylaxis three times per week with a two to three days interval in children with newly-diagnosed AML. A patient will be considered evaluable for safety…