{"description":"Combined AE data for all enrolled participants are reported because few arms had \\<=3 participants which poses a risk of participant identification with rare indications in this study. Treatment-emergent SAEs includes events collected retrospectively and prospectively per protocol. Non-serious AEs were not collected, hence reported as '0'. In participant flow, 'Deaths' are reported as a reason for study discontinuation, whereas in 'All-Cause Mortality' deaths due to any cause are reported.","eventGroups":[{"deathsNumAffected":32,"deathsNumAtRisk":58,"description":"All eligible participants with EBV+ received IV infusion of tabelecleucel or donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":40,"seriousNumAtRisk":58,"title":"Overall Total"}],"frequencyThreshold":"0","seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":4}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":2}],"term":"Haemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Hypopituitarism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Anal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Diarrhoea haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Odynophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Device related thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":4}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":58,"numEvents":14}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Renal transplant failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Serum sickness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58,"numEvents":9}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Ear 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infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Sinusitis bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":4}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Kaposi's sarcoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Non-Hodgkin's lymphoma recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and 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(22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Nervous system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":3}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Mental status 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(22.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58,"numEvents":7}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Obstructive airways disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Organising pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58,"numEvents":5}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":2}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Pulmonary haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58,"numEvents":2}],"term":"Venoocclusive disease"}],"timeFrame":"From Day 1 through 251.1 months after Day 1 dose"}