{"denomUnitsSelected":"Participants","description":"An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 56 months","title":"Number of Participants With One or More Adverse Events (AEs)","type":"SECONDARY"}