{"denomUnitsSelected":"Participants","description":"An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 78 months","title":"Number of Participants Who Experience One or More Adverse Events (AEs)","type":"SECONDARY"}