Symptoms and General Pathology

All Conditions

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Syndrome

Preleukemia

Myelodysplastic Syndromes

Vomiting

Constipation

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Abdominal Pain

Iron Overload

Bone Marrow Diseases

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Iron Metabolism Disorders

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All Drugs and Chemicals

Iron

Deferasirox

Chelating Agents

Iron Chelating Agents

Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food

Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal

Novartis Pharmaceuticals

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.

Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

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.

Study was prematurely terminated and not powered for efficacy.

ICL am

ICL pm

Deferasirox am

Deferasirox pm

Total

Age, Continuous

Sex: Female, Male

Study Director

Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms

Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.

Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups

Difference in Severity of Overall GI AEs Between the Two Treatment Groups

Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups

Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups

the Difference Between the Time From Baseline to the First Occurrence of GI AEs Between the Two Treatment Groups

Difference in Severity of GI Symptoms, Bowel Habits and Level of Satisfaction From the Patient's Perspective Between the Two Treatment Groups

Difference in Reducing Serum Ferritin After Each Month of Study Drug Administration Between the Two Groups

Overall Study

Diseases and Abnormalities at or Before Birth

Anemia

Thalassemia

Hemolysis

Anemia, Hemolytic

Anemia, Hemolytic, Congenital

Hemoglobinopathies

Genetic Diseases, Inborn

This study will evaluate the efficacy and safety of deferasirox in patients with MDS, thalassemia and rare anemia patients with transfusion iron overload.

This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.

1 Year, Open-label Multicenter Evaluation of Efficacy, Safety of Deferasirox in Patients MDS, Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study	NCT01326845	Myelodysplastic... Transfusional I...	Deferasirox	18 Years -	Novartis
This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.	NCT01250951	Myelodysplastic... Thalassemia	Deferasirox	2 Years -	Novartis

Spots Global Cancer Trial Database for transfusional iron overload