Safety
cirrhosis, pruritus, SD, insomnia
ATRIOVENTRICULAR BLOCK, RHEUMATOID ARTHRITIS, CIRRHOSIS, ADENOID CYSTIC CARCINOMA, ADVERSE EVENT
Mean (SD) duration of exposure was 17.7 (11.7) weeks in the total population. The large SD is due to the early termination of the study with patients having a wide range of treatment durations. Overall, the proportion of patients with ≥1 TEAE was greater in the placebo group (73.6%) versus either the seladelpar 5-mg (62.9%) or 10-mg (65.2%) groups (Table Summary of safety eventsAbbreviations: n, number of patients in the category; N, number of patients in the treatment group; TEAE, treatment-emergent adverse event.Six patients discontinued study drug due to TEAEs: 2 in the placebo group (increased bilirubin and atrioventricular block), 2 in the seladelpar 5-mg group (pruritus and adenoid cystic carcinoma), and 2 in the seladelpar 10-mg group (pruritus, insomnia, and rheumatoid arthritis). No grade 3 or greater elevations in serum aminotransferase activity were reported, and no muscle, renal, or pancreatic safety concerns were reported. The safety profile was comparable between patients with and without cirrhosis at baseline (Supplemental Table S6, 