{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"9.2","value":"6.2"},{"comment":"The upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.","groupId":"OG001","lowerLimit":"20.2","upperLimit":"NA","value":"28.7"},{"groupId":"OG002","lowerLimit":"4.8","upperLimit":"6.5","value":"6.2"},{"groupId":"OG003","lowerLimit":"7.1","upperLimit":"14.7","value":"9.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"136"},{"groupId":"OG003","value":"150"}],"units":"Participants"}],"description":"The time difference between the dates of first response and first progression; patients who do not progress are considered censored. Note: for Arm 2 (dMMR Cohort), the upper limit of the confidence interval is not able to be estimated due to an insufficient number of events.","dispersionType":"95% Confidence Interval","groups":[{"description":"COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"(dMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)"},{"description":"COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"(dMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)"},{"description":"COMBINATION PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive placebo IV over 30 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"(pMMR Cohort): Arm 1: Active Comparator (Placebo, Paclitaxel, Carboplatin)"},{"description":"COMBINATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle, paclitaxel IV over 3 hours on day 1 of each cycle, and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with SD or PR who still have measurable disease may continue treatment for up to a total of 10 cycles (if deemed necessary by the treating physician) in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 6 weeks for up to 14 cycles in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"(pMMR Cohort): Arm 2: Experimental (Pembrolizumab, Paclitaxel, Carboplatin)"}],"paramType":"MEDIAN","populationDescription":"Randomized patients with objective tumor response","reportingStatus":"POSTED","timeFrame":"For the duration of objective response, the interquartile range is (4.24 months, 7.92 months); the maximum is 28.68 months.","title":"Duration of Objective Response","type":"SECONDARY","unitOfMeasure":"Months"}