{"description":"Adverse Event: Any sign or symptom that occurs during the study treatment + 30 days post treatment. 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(27.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":2,"numAtRisk":265}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Pulmonary toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Cutaneous vasculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Erythema nodosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Pyoderma gangrenosum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Arterial thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"Peripheral artery thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":263},{"groupId":"EG001","numAffected":1,"numAtRisk":265}],"term":"Thrombophlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (27.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":263},{"groupId":"EG001","numAffected":0,"numAtRisk":265}],"term":"White coat hypertension"}],"timeFrame":"Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 43.5 months (sabatolimab plus AZA) and 42.6 months (placebo + AZA). Deaths were collected from randomization until end of trial, approx. 52 months."}