5 results
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
The purpose of the study is to investigate how quickly and to what extent 2 different production batches of alpelisib (FMI and FMIopt) are absorbed and eliminated from the body (this is called pharmacokinetics). In this study it is investigated…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)