Study Complete
Sponsor ID
20030232
Treatment of Anemia in Subjects with Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
Study Details
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
Protocol Summary
Primary Outcome Measures
Incidence of red blood cell (RBC) transfusion from week 5 to End of Treatment Period (EOTP)
Timeframe: from week 5 to EOTP
Secondary Outcome Measures
Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dL in the absence of RBC transfusions in the preceding 28 days from week 5 to EOTP
Timeframe: from week 5 to EOTP
Number of RBC transfusions from week 5 to EOTP
Timeframe: from week 5 to EOTP
Change in FACT-Fatigue subscale score from baseline to EOTP
Timeframe: from baseline to EOTP
Change in FACT-G Physical Well-being subscale from baseline to EOTP
Timeframe: from baseline to EOTP
Incidence and severity of adverse events
Timeframe: throughout study
Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study
Timeframe: at any time on study
Change in FACT-G total score from baseline to EOTP
Timeframe: from baseline to EOTP
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences
Timeframe: throughout study
Change in EQ-5D Thermometer from baseline to EOTP
Timeframe: from baseline to EOTP
Change in BSI Anxiety scale score from baseline to EOTP
Timeframe: from baseline to EOTP
Change in BSI Depression scale score from baseline to EOTP
Timeframe: from baseline to EOTP
Change in number of caregiver hours from baseline to EOTP
Timeframe: from baseline to EOTP
Incidence of a confirmed antibody formation to darbepoetin alfa
Timeframe: throughout study
Locations
No locations found.