Page 222 - 2021_12-Haematologica-web

Letters to the Editor
The FACIT-Fatigue-evaluable population comprised 225 of 238 patients (94.5%) randomized to Oral-AZA and 219 of 234 patients (93.6%) randomized to placebo, and the EQ-5D-3L–evaluable population included 225 and 217 patients, respectively. Baseline demographic and disease characteristics of HRQoL-evaluable patients were balanced between treatment arms (Online Supplementary Table S1). FACIT-Fatigue and EQ-5D-3L compliance rates
were >95% in both treatment arms at baseline and remained high (>85%) across postbaseline visits except at EOT (~65%), suggesting that HRQoL endpoints were unlikely to be confounded by missing data. Patient- reported FACIT-Fatigue, EQ-5D-3L HUI, and EQ-5D VAS scores were comparable between treatment groups at baseline and similar to reference values from general pop- ulations in the United States (FACIT-Fatigue) and
A
B
C
Figure 2. Kaplan-Meier estimated times to confirmed deterioration from baseline. (A) FACIT-Fatigue scale. (B) EQ-5D-3L health utility index. (C) EQ-5D visual analogue scale scores. Time to definitive deterioration was defined as time from randomization to clinically meaningful deterioration sustained from ≥2 consec- utive assessment visits. cAZA: azacitidine; FACIT: functional assessment of chronic illness therapy; CI: confidence interval; HR: hazard ratio.
3242
haematologica | 2021; 106(12)