Additional Relevant Details The study compared the safety of formoterol, a LABA, used in combination with budesonide, an inhaled corticosteroid (ICS)–the two active therapies in SYMBICORT pressurized metered dose inhaler (pMDI)–against budesonide (pMDI) to evaluate the risk of serious asthma-related events. These events are defined as a composite endpoint of asthma related events including asthma-related deaths, intubations, and hospitalizations, with time to first serious asthma-related event as the primary endpoint.The results showed a comparable risk of serious asthma-related events when formoterol was combined with budesonide versus budesonide alone. Based on a predefined non-inferiority margin, the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) of the primary safety endpoint needed to be less than two. As a result, the findings demonstrated statistical non-inferiority of SYMBICORT to budesonide for time to first serious asthma-related event (HR [1.073], 95% CI, [0.698-1.650]). Furthermore, SYMBICORT therapy resulted in a 16.5% lower risk of asthma exacerbations than budesonide (HR, 0.835; 95% CI, 0.745 to 0.937; P = 0.002).