{"description":"AE is any sign or symptom that occurs during the post-infusion period (starting at the day of first infusion of CTL019 until the end of the study) and safety follow-up. Deaths in post treatment survival follow-up are not considered Adverse Events while still included in the All-Cause Mortality table. Adverse\n\nAdverse event data were pre-specified in the secondary objectives to be analyzed for all treated patients as one group.","eventGroups":[{"deathsNumAffected":76,"deathsNumAtRisk":115,"description":"Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US and at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.","id":"EG000","otherNumAffected":113,"otherNumAtRisk":115,"seriousNumAffected":84,"seriousNumAtRisk":115,"title":"Tisagenlecleucel - All Patients"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":115}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":115}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":115}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":115}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":115}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":115}],"term":"Abdominal 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(25.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":115}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":115}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":115}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":115}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":115}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":115}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":115}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":115}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":115}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":115}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system 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(25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":115}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":115}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":115}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":115}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":115}],"term":"Blood immunoglobulin G 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(25.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":115}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":115}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":115}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":115}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":115}],"term":"Back 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(25.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":115}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":115}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":115}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":115}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":115}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, 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(25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Cardio-respiratory arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Cardiopulmonary failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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(25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Polyarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Acute myeloid leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Invasive ductal breast carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and 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mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Pharyngeal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":115}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":115}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":115}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (25.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":115}],"term":"Hypotension"}],"timeFrame":"Adverse Events (AEs) were collected during the post-infusion period (starting at the day of 1st infusion until the end of the study), up to maximum duration of 61 months for each patient. Deaths were collected at all points post-infusion until the patient completed the study duration (60 months) or further safety follow-up under the study protocol. Therefore on-treatment deaths include post-infusion deaths until Last patient Last Visit (LPLV)."}