{"description":"New infections and all unrelated SAEs were reported until 9 months after the last dose of study treatment. All related SAEs were reported indefinitely. Secondary malignancies were reported until the end of the study or initiation of a new anti-leukemia treatment, whichever was earlier.","eventGroups":[{"description":"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG000","otherNumAffected":13,"otherNumAtRisk":16,"seriousNumAffected":5,"seriousNumAtRisk":16,"title":"Part 1: Rituximab SC 1400 mg"},{"description":"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG001","otherNumAffected":16,"otherNumAtRisk":17,"seriousNumAffected":8,"seriousNumAtRisk":17,"title":"Part 1: Rituximab SC 1600 mg"},{"description":"PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG002","otherNumAffected":21,"otherNumAtRisk":22,"seriousNumAffected":4,"seriousNumAtRisk":22,"title":"Part 1: Rituximab SC 1870 mg"},{"description":"One participant enrolled in the rituximab SC 1870 mg subcohort received 1000 mg rituximab SC during Cycle 6 in error.\n\nParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG003","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Part 1: Rituximab SC 1000 mg"},{"description":"These participants were withdrawn prior to SC treatment.","id":"EG004","otherNumAffected":7,"otherNumAtRisk":8,"seriousNumAffected":3,"seriousNumAtRisk":8,"title":"Part 1: No SC Dose Received"},{"description":"Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG005","otherNumAffected":80,"otherNumAtRisk":89,"seriousNumAffected":35,"seriousNumAtRisk":89,"title":"Part 2 : Rituximab IV 500 mg/m^2"},{"description":"Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"EG006","otherNumAffected":81,"otherNumAtRisk":85,"seriousNumAffected":32,"seriousNumAtRisk":85,"title":"Part 2: Rituximab SC 1600 mg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":16},{"groupId":"EG001","numAffected":8,"numAtRisk":17},{"groupId":"EG002","numAffected":9,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":1},{"groupId":"EG004","numAffected":3,"numAtRisk":8},{"groupId":"EG005","numAffected":51,"numAtRisk":89},{"groupId":"EG006","numAffected":54,"numAtRisk":85}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":16},{"groupId":"EG001","numAffected":6,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":15,"numAtRisk":89},{"groupId":"EG006","numAffected":16,"numAtRisk":85}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":8},{"groupId":"EG005","numAffected":21,"numAtRisk":89},{"groupId":"EG006","numAffected":11,"numAtRisk":85}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":17},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":1,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":25,"numAtRisk":89},{"groupId":"EG006","numAffected":20,"numAtRisk":85}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Agranulocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Granulocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":6,"numAtRisk":17},{"groupId":"EG002","numAffected":4,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":8},{"groupId":"EG005","numAffected":31,"numAtRisk":89},{"groupId":"EG006","numAffected":32,"numAtRisk":85}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":7,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":8},{"groupId":"EG005","numAffected":20,"numAtRisk":89},{"groupId":"EG006","numAffected":18,"numAtRisk":85}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":4,"numAtRisk":17},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":9,"numAtRisk":89},{"groupId":"EG006","numAffected":10,"numAtRisk":85}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":2,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Abdominal pain upper"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":7,"numAtRisk":89},{"groupId":"EG006","numAffected":7,"numAtRisk":85}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":5,"numAtRisk":89},{"groupId":"EG006","numAffected":7,"numAtRisk":85}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Mouth ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Abdominal discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Gingival erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Gingival pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":0,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Haemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Odynophagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":5,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":23,"numAtRisk":89},{"groupId":"EG006","numAffected":26,"numAtRisk":85}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":17},{"groupId":"EG002","numAffected":1,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":8},{"groupId":"EG005","numAffected":9,"numAtRisk":89},{"groupId":"EG006","numAffected":12,"numAtRisk":85}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":3,"numAtRisk":17},{"groupId":"EG002","numAffected":3,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":14,"numAtRisk":85}],"term":"Injection site 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(20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16},{"groupId":"EG001","numAffected":2,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Chest discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16},{"groupId":"EG001","numAffected":1,"numAtRisk":17},{"groupId":"EG002","numAffected":0,"numAtRisk":22},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":8},{"groupId":"EG005","numAffected":0,"numAtRisk":89},{"groupId":"EG006","numAffected":0,"numAtRisk":85}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General 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