Adverse events
nasal mucosal dryness, death, fever, throat dryness, throat, cough, nasal congestion, headache
ADVERSE EVENTS, EVENTS, ALLERGIC REACTION, AUTOIMMUNE REACTION
In the safety analysis, ≥1 AE was reported by 221 of 901 (25%) and 72 of 321 (22%) participants in the SA58 and placebo groups, respectively. All of the reported AEs were Grade one events as judged by study investigator. No SAEs and AESIs were reported by study participants, and no AEs led to study withdrawal or death during the short monitoring period. The most common AEs included nasal mucosal dryness (5%), runny nose (3%), fever (3%), nasal congestion (3%), headache (2%), cough (2%), and throat dryness (2%) etc. There was no significant difference in the occurrence of the above AEs between the SA58 and placebo groups (Summary of adverse events.Note: AEs: adverse events; SAEs: severe adverse events; AESI: adverse events of special interest (i.e. allergic reaction, autoimmune reaction, and nasal and throat AEs of Grade 2 and above).Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities, version 24.0.