{"denomUnitsSelected":"Participants","description":"An adverse event occurring after the procedure is serious if it causes death, endangers the life of the person who is suitable for research, requires or prolongs hospitalization, causes a significant handicap, results in a congenital malformation, or is considered medically significant.","reportingStatus":"NOT_POSTED","timeFrame":"6 months","title":"Number of Severe Adverse Events","type":"SECONDARY"}