{"description":"Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 dose of INCB099280 or axitinib.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants received INCB099280 400 milligrams (mg) twice daily (BID) and axitinib 5 mg BID in consecutive 21-day cycles for up to 2 years as long as they were receiving benefit and did not meet any criteria for study withdrawal.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":1,"seriousNumAtRisk":5,"title":"INCB099280 400 mg BID Plus Axitinib 5 mg BID"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypoacusis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gastrointestinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Catheter site infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Posterior reversible encephalopathy syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Miliaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Skin plaque"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":5}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 27.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Vision blurred"}],"timeFrame":"up to approximately 1 year"}