{"description":"The safety analysis population included all patients who received at least one dose of trial treatment and had at least one safety follow-up, whether withdrawn prematurely or not. 272 patients received FC only and 274 patients received FCR.","eventGroups":[{"description":"Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.","id":"EG000","otherNumAffected":232,"otherNumAtRisk":272,"seriousNumAffected":132,"seriousNumAtRisk":272,"title":"Fludarabine+Cyclophosphamide (FC)"},{"description":"Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.","id":"EG001","otherNumAffected":251,"otherNumAtRisk":274,"seriousNumAffected":138,"seriousNumAtRisk":274,"title":"Fludarabine+Cyclophosphamide+Rituximab (FCR)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":110,"numAtRisk":272},{"groupId":"EG001","numAffected":120,"numAtRisk":274}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":272},{"groupId":"EG001","numAffected":55,"numAtRisk":274}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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Leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":272},{"groupId":"EG001","numAffected":0,"numAtRisk":274}],"term":"Mycobacterial Infection"}],"timeFrame":"Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months)."}