darbepoetin alfa and anemia of cancer
Study Details
This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy. Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
Protocol Summary
Number of Participants Hospitalized during the Test Period
Timeframe: Weeks 1- 12
Days of Hospitalization during the Test Period
Timeframe: Weeks 1-12
Number of Hospitalizations during the Test Period
Timeframe: Weeks 1-12
Total Hospital Costs during the Test Period
Timeframe: Weeks 1-12
Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
Timeframe: Baseline (Week 1) and Week 13
Hemoglobin Response during the Test Period
Timeframe: Weeks 1-12
Hematopoietic Response during the Test Period
Timeframe: Weeks 1-12
Change from Baseline in Hemoglobin Level
Timeframe: Baseline (Week 1) and Week 13
Number of Participants with Red Blood Cell (RBC) Transfusions during the Test Period
Timeframe: Weeks 1-12
Number of Units of Red Blood Cells Transfused during the Test Period
Timeframe: Weeks 1-12
Number of Days of Red Blood Cell Transfusions during the Test Period
Timeframe: Weeks 1-12
Number of Participants with Red Blood Cell (RBC) Transfusions during Weeks 5-12
Timeframe: Weeks 5-12
Number of Units of Red Blood Cells Transfused during Weeks 5-12
Timeframe: Weeks 5-12
Number of Days of Red Blood Cell Transfusions during Weeks 5-12
Timeframe: Weeks 5-12