Table 4.
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) |
aPatients missing a valid baseline and post-baseline FACT-F score were omitted from the analysis
bPatients missing a valid baseline and Week 13 FACT-F score were omitted from the analysis
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.
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