Safety
deaths, dyspepsia, headache
ASTHMA, ULCERATIVE COLITIS
A total of 13 AEs was reported in 11 patients, 12 of which were reported by 10 patients in the selnoflast arm. All AEs were mild (Grade 1), with the exception of one AE of Grade 2 severity (asthma; unrelated to the study drug). The most frequently reported AEs (by Preferred Term [PT]) in the selnoflast arm were headache and dyspepsia (two patients each [15.4%]); all other AEs were reported once in individual patients. One patient in the placebo arm experienced a single AE of headache. Three AEs (23.1%) in the selnoflast arm (dyspepsia [two patients] and headache [one patient]) and one AE (16.7%) in the placebo arm (headache) were considered treatment‐related. No AEs led to treatment discontinuation or dose interruption. There were no serious AEs or deaths during the study. There were no clinically meaningful changes in clinical chemistry (including liver function tests), urinalysis, vital signs, ECGs, or other safety parameters. A summary of the safety findings is provided in Table Summary of safety results in patients with ulcerative colitis.