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Table 4 Change in FACT-F score

From: Comparison of darbepoetin alfa dosed weekly (QW) vs. extended dosing schedule (EDS) in the treatment of anemia in patients receiving multicycle chemotherapy in a randomized, phase 2, open-label trial

 

QW

EDS

Difference

 

(n = 374)

(n = 378)

(QW - EDS)

Baseline FACT-F score

   

   Patients included in the analysisa

330

337

 

   Mean (SD)

29.7 (12.4)

29.9 (12.4)

 

Change in FACT-F score from baseline to Week 13

   

   Patients included in the analysisb

256

268

 

   Least squares mean (95% CI) c

1.8 (0.5, 3.1)

2.5 (1.2, 3.7)

-0.7 (-2.3, 0.9)

≥3-point increase in FACT-F score from baseline

   

   Patients included in the analysisa

330

337

 

   Through Week 13, n (%)

111 (34)

132 (39)

 

   Through the end of treatment, n (%)

155 (47)

173 (51)

 
  1. aPatients missing a valid baseline and post-baseline FACT-F score were omitted from the analysis
  2. bPatients missing a valid baseline and Week 13 FACT-F score were omitted from the analysis
  3. cThe least squares means and CIs were computed from an ANOVA model after adjusting for the stratification factors at randomization (chemotherapy cycle length, screening hemoglobin, and tumor type), and baseline FACT-F score.
  4. FACT-F = Functional Assessment of Cancer Therapy-Fatigue; QW = once weekly; EDS = extended dosing schedule; SD = standard deviation; CI = confidence interval; ANOVA = analysis of variance