Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study
Status:
Terminated
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to evaluate and compare the frequency and severity of GI
adverse events in different dose administration regimens. The patient population consists of
low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional
iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day
deferasirox or an evening dose of the same. Patients are then followed up for 6 months for
any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.