Safety
deaths, Treatment-emergent adverse events, TEAEs
ADVERSE EVENTS, EVENTS, UPPER RESPIRATORY TRACT INFECTION
Overall, a total of 266 AEs were reported, in 40 (97.6%) subjects (except 1 subject from placebo group), of which 254 were treatment-emergent AEs (TEAEs). A total of 168 drug-related AEs were reported in 34 (82.9%) subjects with 3 (100%), 6 (60.0%), 6 (100%), 5 (83.3%), 5 (83.3%), and 9 (90.0%) subjects from WBP216 10|, 30, 75, 150, 300 mg, and placebo groups, respectively. One subject (A205) from WBP216 30 mg group experienced serious AE (SAE) (myocardial bridging) of Grade 1 severity, which was resolved with no concomitant medication/non-pharmacological therapy indicating SAE non-relevant to the study drug.Most TEAEs (40 subjects, 97.6%) reported in the study were of grade 1 severity. Grade 2 TEAEs were reported by 20 (48.8%) patients, whereas only 2 (4.9%) subjects experienced Grade 3 TEAEs (upper respiratory tract infection, and decrease in neutrophil count). No subjects reported Grade 4 TEAEs and TEAEs that led to withdrawal from the study, or deaths during the study. The TEAEs with total incidence of ≥5.0% (WBP216 vs placebo) are presented in Treatment-emergent adverse events (with total incidence ≥5.0%): Safety analysis set.n1 = number of events; n = number of subjects.MedDRA version 19.0 was used to code adverse events.