{"description":"An AE is any untoward medical occurrence whether or not related to the study drug that appears to change in intensity during the course of the study.\n\nAbnormal laboratory values or diagnostic test results constitute AEs only if they induce clinical signs or symptoms or require treatment or further diagnostic tests Hospitalization for elective surgery or routine clinical procedures that are not the result of an AE (e.g.,surgical insertion of central line) should not be recorded as an AE.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle.\n\nNivolumab 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.\n\nCabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms).","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Nivolumab + Cabiralizumab"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":5}],"term":"PERIORBITAL EDEMA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"ABDOMINAL PAIN"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"DIARRHEA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":4}],"term":"MUCOSITIS ORAL"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"NAUSEA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"VOMITING"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"CHILLS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"FATIGUE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"FEVER"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"NON-CARDIAC CHEST PAIN"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"INFECTIONS AND INFESTATIONS - OTHER, SPECIFY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2}],"term":"UPPER RESPIRATORY INFECTION"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"WEIGHT LOSS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2}],"term":"ANOREXIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Liposarcoma","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"HEADACHE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"INSOMNIA"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"COUGH"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"NASAL CONGESTION"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"SORE THROAT"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"PRURITUS"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"ADRENAL INSUFFICIENCY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"ENDOCARDITIS INFECTIVE"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAEv5","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1}],"term":"SEPSIS"}],"timeFrame":"From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months"}