{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"37"}]}],"title":"Gastrointestinal Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"31"}]}],"title":"Hepatic Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"8"}]}],"title":"Pulmonary Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"18"}]}],"title":"Renal Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"53"}]}],"title":"Skin Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"title":"Hypersensitivity/Infusion Reaction Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"13"}]}],"title":"Endocrine Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"230"}],"units":"Participants"}],"description":"An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.\n\nSelect AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.","groups":[{"description":"Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)","id":"OG000","title":"Nivolumab + SOC Chemotherapy"},{"description":"Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).","id":"OG001","title":"Placebo + SOC Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who received at least one dose of study medication in neoadjuvant or adjuvant setting.","reportingStatus":"POSTED","timeFrame":"From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)","title":"The Number of Participants With Select Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}