{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"124"},{"groupId":"OG003","value":"151"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"106"},{"groupId":"OG001","value":"109"},{"groupId":"OG002","value":"274"},{"groupId":"OG003","value":"276"}],"units":"Participants"}],"description":"Assessed by Common Terminology Criteria for Adverse Events (CTCAE V5.0). The endpoint is the count of participants with an adverse event of grade 3 (or higher) by treatment group.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"All randomized patients","reportingStatus":"POSTED","timeFrame":"For the adverse event time frame, the interquartile range was (0.79 months, 3.42 months); the maximum was 28.39 months.","title":"Adverse Events With Grade 3 (or Higher)","type":"SECONDARY","unitOfMeasure":"Participants"}