Safety and tolerability measures
ELECTROLYTE IMBALANCES, ADVERSE EVENT, ADVERSE EVENT, BLOOD, ADVERSE EFFECTS, EVENTS
To assess the adverse effects, safety, and tolerability of the GA/18β drug, we examined biochemical markers related to liver and kidney function, fluid and electrolyte balance, glucose levels, and vital signs. Blood samples were collected using 5.6 mL and 4 mL Vacutainer tubes and stored at -70°C until analysis of parameters at certified clinical laboratories in Mexico City.Vital sign parameters were quantified at days 0-16 and day 30, while laboratory health markers were measured at days 0, 3, 8, 16, and 30 to identify potential changes throughout the treatment and follow-up period.Adverse events (AEs) included electrolyte imbalances or shifts in blood chemistry parameters, as well as both serious and non-serious events in accordance with the CTCAE v 5.0 Common Terminology Criteria for Adverse Events scale. AEs were documented through exploration, directed questioning, and assessment of laboratory analyses. Clinical evaluation of AEs, utilization, and discontinuation of concomitant medications were recorded from the initial day of treatment through the final day of the follow-up period.