{"denomUnitsSelected":"Participants","description":"Number of participants with a maximum grade of 3 or higher that occurred during follow-up period. Adverse events are graded and categorized using CTCAE v4.0.","reportingStatus":"NOT_POSTED","timeFrame":"Up to 5 years","title":"Number of Participants With Adverse Events (Grade 3 or Higher) That Occurred During Follow-Up Period","type":"OTHER_PRE_SPECIFIED"}