Mixed‐effect model for repeated measure analyses
SE
MYELOPROLIFERATIVE NEOPLASM, TSS
Change in total scores on the modified MPN‐SAF v2.0 by treatment is shown in Table MMRM‐based TSS change from baseline.Abbreviations: BAT, best available therapy; LS, least squares; MPN‐SAF, Myeloproliferative Neoplasm Symptom Assessment Form; MMB, momelotinib; MMRM, mixed‐effect model for repeated measure; RUX, ruxolitinib; SE, standard error; TSS, total symptom score.The primary model includes treatment, time, treatment × time, age, race.Comparing between‐treatment groups, a slightly greater reduction in the Week 24 LS mean change scores from baseline was observed in the ruxolitinib treatment group compared with the momelotinib treatment group (a difference of 1.24 points in the overall population). The differences in the overall population did not exceed the ‐2.90 non‐inferiority 50% fraction of the margin and was near the −1.45 non‐inferiority 75% fraction of the margin. Similar results were observed in the symptomatic population, where a difference of 1.26 points did not exceed the −4.14 non‐inferiority 50% fraction of the margin or the −2.07 non‐inferiority 75% fraction of the margin (Table In SIMPLIFY‐2, the LS mean scores progressively decreased from baseline to Week 24 for the momelotinib group, and progressively increased in the BAT group. Specifically, in the overall population, LS mean change from baseline was −3.80 at Week 24 in the momelotinib group, and +2.75 at Week 24 in the BAT group (Table Cumulative distribution function of change in MPN‐SAF TSS from baseline at Week 24 by treatment in the symptomatic populations of SIMPLIFY‐1 and SIMPLIFY‐2 are shown in Figure Cumulative distribution function of absolute change in MPN‐SAF TSS from baseline to Week 24 in the (A) SIMPLIFY‐1 symptomatic population and (B) SIMPLIFY‐2 symptomatic population. BAT, best available therapy; MPN‐SAF, Myeloproliferative Neoplasm Symptom Assessment Form; TSS, total symptom score.