Safety assessments
ADVERSE EVENTS, EVENT
Safety and tolerability were assessed by evaluating vital signs (supine blood pressure, pulse rate, respiratory rate, and body temperature), 12-lead electrocardiogram (ECG) parameters, clinical laboratory assessments, and adverse events (AEs). AEs were considered treatment emergent if they occurred after the first administration of dersimelagon or if a predose event increased in severity following dosing. The frequency and incidence of treatment-emergent AEs (TEAEs) were summarized by system organ class and preferred term for each treatment group. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0. Safety laboratory test results, vital signs, and ECG parameters were summarized by treatment group and planned sampling point. All participants in the study (N = 144) were included in the safety analysis population.