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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Novartis Investigative Site
Caen, Cedex, France
Novartis Investigative Site
Brest, France
Novartis Investigative Site
Limoges, France
Novartis Investigative Site
Pessac, France
Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms
Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.
Time frame: 3 months
Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.
Study was prematurely terminated and not powered for efficacy.
Time frame: 6 months
Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups
Study was prematurely terminated and not powered for efficacy.
Time frame: months 3 and 6.
Difference in Severity of Overall GI AEs Between the Two Treatment Groups
Study was prematurely terminated and not powered for efficacy.
Time frame: months 3 and 6.
Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups
Study was prematurely terminated and not powered for efficacy.
Time frame: months 3 and 6
Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups
Study was prematurely terminated and not powered for efficacy.
Time frame: months 3 and 6
the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups
Study was prematurely terminated and not powered for efficacy.
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Novartis Investigative Site
Vandœuvre-lès-Nancy, France
Novartis Investigative Site
Alessandria, AL, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Roma, Italy
Novartis Investigative Site
Bloemfontein, South Africa
Novartis Investigative Site
Madrid, Madrid, Spain
Time frame: 3 months, 6 months
Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups
Time frame: 3 months, 6 months
Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups
Study was prematurely terminated and not powered for efficacy.
Time frame: 3 months, 6 months