{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 mucositis oral"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 sepsis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 adrenal insufficiency"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Grade 3 endocarditis infective"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"description":"Assess and summarize adverse events (AEs) using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.","groups":[{"description":"Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 \\[IgG4\\]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles.\n\nCabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles.","id":"OG000","title":"Nivolumab + Cabiralizumab"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Average of 9.5 Months","title":"Summarize Adverse Events","type":"SECONDARY","unitOfMeasure":"number of events"}