Safety Monitoring

Adverse events are defined as unfavorable medical occurrences during the study period that may be related to the intervention. The protocol distinguishes adverse events from intervention-related adverse reactions. Severe hypokalaemia, defined as potassium below 2.5 mEq/L, requires immediate study drug discontinuation. Dose adjustment is not permitted in the trial. If potassium is above the age- and sex-specific upper limit of normal or persistent hypotension is present, the losartan dose is reduced by 25 mg. The protocol does not plan an independent data monitoring committee because both devices are approved and routine low-risk ureteroscopic interventions. Thyroid cancer risk is a focus because existing observational evidence is conflicting. Serious adverse events will be adjudicated and treatment-group incidence differences evaluated. Evidence on pancreatitis risk is mixed, with some older database signals but no significant increase in large cardiovascular outcome trials of newer agents. Current FDA evidence does not establish causality between GLP-1 receptor agonists and suicide. Complications are classified with the Clavien-Dindo system to support comparability with other stu…