4 results
In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.
Primary endpoint:- Successful desensitization for Mesalazine in ulcerative colitis patients with a presumed history of intolerance for Mesalazine. Secondary endpoint:- To investigate if a presumed intolerance for Mesalazine may be reproducible in a…
Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…
EFFICACY OBJECTIVESWithin each cohort, the study has the following co-primary efficacy objectives:· Assessing early efficacy during the Maintenance Treatment Phase based on a 20%reduction in tumour size after 2 months of treatment· Evaluating PFSThe…