Change from Baseline in MDASI-CML Symptom Severity Score (MMRM analysis).
nausea, diarrhea, fatigue, vomiting, dry mouth
DRY MOUTH
BSL = baseline, CI = confidence interval, LS mean=least squares mean, WK = week. Score ranges from 0 to 10, with a higher score indicating greater symptom severity/interference. Number of patients remaining on treatment at each timepoint shown for asciminib and bosutinib. Negative change shows improvement; positive change indicates deterioration.Patients in the asciminib arm maintained or showed a decreasing trend in severity in all individual MDASI-CML symptom items (demonstrating decreasing severity in 15 out of 20 symptoms); the most notable decreases in symptom severity reported in the overall timeframe were in the symptoms of fatigue (which was the highest at baseline) and having a dry mouth, although these decreases in scores were not clinically meaningful (Supplementary Table In contrast, patients’ scores in the bosutinib arm remained stable for the majority of symptoms, with increases in severity observed for the symptoms of diarrhea, nausea, and vomiting. For diarrhea, an increase of severity from baseline in bosutinib-treated patients of at least 1 point at all timepoints was reported, with the greatest increase in severity observed as early as week 4 (2.6 points more severe compared to baseline). The overall mean increase in diarrhea severity score was 1.5 points, suggesting that it may be a clinically meaningful worsening (based on the MID threshold of 1.5 points) (overall change from baseline data presented in Supplementary Table The difference between treatment arms in the MDASI-CML mean symptom and interference scores (per MMRM analysis of 48-week data) are shown in Fig. 