{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"17"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"73"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"271"},{"groupId":"OG001","value":"268"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"54"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"24"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"434"},{"groupId":"OG001","value":"439"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event was during the on-treatment period (time from the first dose of study treatment through 90 days after last dose of study treatment or start day of new anti-cancer drug therapy-1 day). As per NCI-CTCAE v4.03, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From start of study treatment until 90 days after last dose of study treatment (maximum up to approximately 92 months)","title":"Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute -Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (V) 4.03","type":"SECONDARY","unitOfMeasure":"Participants"}