Dosing and Outcomes Study of Erythropoietic Stimulating Therapies
The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a
prospective, observational multicenter registry of approximately 1200 adult cancer patients
receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration
of the DOSE Registry is three years. Based on initial results, the registry sponsor may
elect to extend the duration of the registry.This study does not specify treatment
protocols, require any particular assignment of patients to treatment protocols, or in any
other way require participating physicians to alter their practice patterns. Participating
physicians are instructed to continue to treat all patients according to their own best
clinical judgment, but to submit information on baseline patient characteristics, treatment
patterns, and clinical outcomes. Baseline determinations will include patient demographics,
tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will
be collected over the 16-week study period with regard to EST treatment, hematologic
outcomes and patient reported outcomes.
Observational Model: Case-Only, Time Perspective: Prospective
To document patient characteristics and patterns of clinical management
The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.
Up to 3 years
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
United States: Food and Drug Administration