{"description":"The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).","eventGroups":[{"deathsNumAffected":30,"deathsNumAtRisk":74,"description":"Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.","id":"EG000","otherNumAffected":59,"otherNumAtRisk":61,"seriousNumAffected":20,"seriousNumAtRisk":61,"title":"Lisocabtagene Maraleucel (JCAR017)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":61}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":61}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":61}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":61}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":61}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":61}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":61}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":61}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":61}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":61}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":61}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":61}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":61}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":61}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":61}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":61}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":61}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":61}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":61}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":61}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":61}],"term":"Orthostatic hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Lower gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":61}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":61}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Stenotrophomonas sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":61}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":61}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":61}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":61}],"term":"Hypotension"}],"timeFrame":"Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (up to approximately 90 days)."}