{"analyses":[{"ciLowerLimit":"1.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"7.3","groupIds":["OG000","OG001"],"nonInferiorityComment":"Difference in percentage based on Miettinen \\& Nurminen method.","nonInferiorityType":"OTHER","paramType":"Difference in Percentage","paramValue":"4.1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"461"},{"groupId":"OG001","value":"444"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"483"},{"groupId":"OG001","value":"486"}],"units":"Participants"}],"description":"An AE was defined as 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. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.","groups":[{"description":"Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \\~1 year) in Part 1.","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \\~1 year) in Part 1.","id":"OG001","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized participants who received at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"Up to ~19.3 months","title":"Number of Participants Who Experienced at Least One Adverse Event (AE)","type":"SECONDARY","unitOfMeasure":"Participants"}