{"analyses":[{"ciLowerLimit":"0.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.82","estimateComment":"Hazard Ratio based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by melanoma T Stage (T3b, T4a, T4b).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.00046","pValueComment":"One-sided p-value based on log-rank test stratified by melanoma T Stage (T3b, T4a, T4b).","paramType":"Hazard Ratio (HR)","paramValue":"0.61","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median, Upper limit and lower limit not reached at the time of data cut-off due to insufficient number of participants with recurrence.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and Upper limit not reached at the time of data cut-off due to insufficient number of participants with recurrence.","groupId":"OG001","lowerLimit":"29.9","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"487"},{"groupId":"OG001","value":"489"}],"units":"Participants"}],"description":"RFS was defined as the time from randomization to any of the following events: recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. Per protocol, final analysis for this primary outcome measure was performed using the initial pembrolizumab or placebo treatment with a protocol-specified analysis data cut-off date of June-21-2021.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to ~32.7 months","title":"Recurrence-free Survival (RFS)","type":"PRIMARY","unitOfMeasure":"Months"}