{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was defined as any adverse event either reported for the first time or the worsening of a pre-existing event after the first dose of study drug. The severity of AEs was assessed using CTCAE v4.03. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death due to AE.","groups":[{"description":"Programmed cell death protein 1 (PD-1)/programmed cell death protein ligand 1 (PD-L1) refractory participants with gastric cancer, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC) were to have received a range of doses of INCAGN01949 found to be safe in Phase 1 in combination with nivolumab, administered as IV infusions.","id":"OG000","title":"Phase 2, Part A: INCAGN01949 + Nivolumab"},{"description":"PD-1/L1 refractory participants with advanced or metastatic gastric cancer, SCCHN, NSCLC, or RCC were to have received a range of doses of INCAGN01949 found to be safe in Phase 1. INCAGN01949 was to have been administered alone, in combination with nivolumab, and in combination with nivolumab and ipilimumab, administered as IV infusions.","id":"OG001","title":"Phase 2, Part B: INCAGN01949; INCAGN01949 + Nivolumab; INCAGN01949 + Nivolumab + Ipilimumab"}],"populationDescription":"Phase 2 of the study did not open for enrollment.","reportingStatus":"POSTED","timeFrame":"up to 24 months","title":"Phase 2: Number of Participants With a Grade 3 or Higher TEAE","type":"SECONDARY"}