{"analyses":[{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.01","estimateComment":"A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0305","pValueComment":"based on stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis","paramType":"Hazard Ratio (HR)","paramValue":"0.75","statisticalMethod":"stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.7","upperLimit":"44.5","value":"32.8"},{"groupId":"OG001","lowerLimit":"15.7","upperLimit":"27.2","value":"22.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"Overall survival was defined as the time from the date of randomization until the date of death due to any cause.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \\[mg/m\\^2\\] on Days 1, 8, and 15).","id":"OG000","title":"Retifanlimab 500 mg Q4W + Chemotherapy"},{"description":"Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.","id":"OG001","title":"Placebo + Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"Full Analysis Set. Median survival time was estimated using Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.","reportingStatus":"POSTED","timeFrame":"up to 56.5 months","title":"Overall Survival","type":"SECONDARY","unitOfMeasure":"months"}