{"analyses":[{"ciLowerLimit":"0.563","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.840","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","pValueComment":"2-sided p-value","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to insufficient number of participants with event.","groupId":"OG000","lowerLimit":"11.1","upperLimit":"NA","value":"13.8"},{"groupId":"OG001","lowerLimit":"6.9","upperLimit":"11.1","value":"8.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"442"},{"groupId":"OG001","value":"444"}],"units":"Participants"}],"description":"PFS: time from the date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20% increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute \\> of at least 5 mm. The appearance of one or more new lesions was also considered progression.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.","id":"OG000","title":"Avelumab + Axitinib"},{"description":"Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.","id":"OG001","title":"Sunitinib"}],"paramType":"MEDIAN","populationDescription":"FAS included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)","title":"PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression","type":"SECONDARY","unitOfMeasure":"Months"}