{"description":"No participants were enrolled in the Neoadjuvant Immunotherapy group.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Patients will proceed to surgical resection with no nivolumab/ipilimumab given prior to surgery.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Standard of Care (no Neoadjuvant Immunotherapy)"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Patients will receive a single dose of neoadjuvant nivolumab and ipilimumab 7 days (± 3 days) prior to surgical resection.\n\nNivolumab: Nivolumab will be given at the FDA-approved dose of 3 mg/kg.\n\nIpilimumab: Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Neoadjuvant Immunotherapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Concentration impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Dysphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0}],"term":"Pyramidal tract syndrome"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Pyramidal tract syndrome"}],"timeFrame":"Approximately 10 days"}