{"denomUnitsSelected":"Participants","description":"An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported.","reportingStatus":"NOT_POSTED","timeFrame":"Up to ~92 months","title":"Number of Participants Who Experienced an Adverse Event (AE)","type":"SECONDARY"}