Figure 3.
Mean changes from baseline, primary HRQoL analysis measures. Reference lines indicate prespecified group-level MID thresholds for clinically meaningful improvement or deterioration. Patients were included in this analysis regardless of their clinical response. The number of nonresponders is as follows: 31 nonresponders at day 1; 27 nonresponders at month 1; 17 nonresponders at month 2; and 10 nonresponders at month 3. Nonresponders were not considered after this time due to the (continued) small sample size (<10 patients). *P < .05 based on two-sided Wilcoxon signed-rank test compared with 0. D, day; M, month; SE, standard error. MID for improvement: −4 Fatigue, −5 Pain, +2 Physical functioning, +3 Cognitive functioning, +5 Global health status/QoL, −10 Disease symptoms, −10 Side effects of treatment. MID for deterioration: +5 Fatigue, +3 Pain, −5 Physical functioning, −1 Cognitive functioning, −5 Global health status/QoL, +10 Disease symptoms, +10 Side effects of treatment.