Safety and tolerability
nausea, myalgia, dyspnea, tachycardia, diarrhea, scratchy throat, low back pain, paresthesia, throat, dizziness, sialorrhea, headache
SIALORRHEA, PARESTHESIA
Based on the percentage of subjects reporting AEs, the most frequent AEs during treatment and follow-up included headache, myalgia, dizziness, and paresthesia. Nevertheless, none of these AEs exceeded 8% within any group. Establishing definitive causality proved challenging due to the overlap of many symptoms with those of COVID-19, including headache, myalgia, dizziness, and paresthesia. For instance, myalgia was reported in both control group and group A subjects at a similar proportion (5.3% of the total patients). Consequently, AEs were attributed to the GA/18β-treated subjects and not the control group. These AEs encompassed dyspnea, scratchy throat, sialorrhea, nausea, tachycardia, diarrhea, and low back pain. Among these, dyspnea and itchy throat were the most frequent at 8.8%, while the rest of AEs were each reported by a single patient (1.8%). Importantly, all reported AEs were classified as non-serious and mild to moderate intensity. Furthermore, most of these AEs (sialorrhea, nausea, tachycardia, and diarrhea) were not reported beyond day 5.