Safety.
deaths, wheezing, concussions
ADVERSE EVENTS
Safety endpoints included electrocardiography and laboratory blood testing, including complete blood counts and differentials, serum chemistries, and liver function tests. A total of 15 adverse events occurred in 5 of 10 patients (50%; Among adverse events not attributed to acalabrutinib, 1 patient experienced recurrent wheezing after her baseline OFC despite treatment with epinephrine and was sent to the emergency department for further management. Two sports-related concussions occurred in 2 patients during the trial that were considered to be unrelated to study drug or procedures; 1 occurred before the patient received acalabrutinib, and 1 occurred 18 days after the patient’s last dose of acalabrutinib. One of these same patients also experienced a separate mechanical fall due to tripping over an object, which occurred before acalabrutinib therapy. No deaths or treatment-related serious adverse events occurred during the trial. No electrocardiographic changes were observed during acalabrutinib treatment.