{"description":"Adverse events are collected on the adverse event form, toxicity form, and myelotoxicity form.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":40,"description":"Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\\^2 and fludarabine 30mg/m\\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression.\n\nLenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression\n\nbb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\\^6 cells.\n\nCyclophosphamide: 300 mg/m\\^2/day for 3 consecutive days prior to the CAR T infusion\n\nFludarabine: 30 mg/m\\^2/day or 3 consecutive days prior to the CAR T infusion\n\nleukapheresis: Placement of central line catheter and leukapheresis","id":"EG000","otherNumAffected":38,"otherNumAtRisk":40,"seriousNumAffected":9,"seriousNumAtRisk":40,"title":"Lenalidomide and bb2121"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Blood alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":9}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Dermal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":5}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":40,"numEvents":129}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":40,"numEvents":98}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":6}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Respiratory syncytial virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Sinus pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":3}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Thrombotic microangiopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":40,"numEvents":65}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":2}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Oedema"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40,"numEvents":5}],"term":"Cytokine Release Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v28.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1}],"term":"Transient ischaemic attack"}],"timeFrame":"All SAEs and AEs were collected from enrollment to study completion, or for 12 months after bb2121 infusion."}