{"description":"Safety Population.","eventGroups":[{"description":"Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.","id":"EG000","otherNumAffected":319,"otherNumAtRisk":369,"seriousNumAffected":155,"seriousNumAtRisk":369,"title":"Rituximab SC"},{"description":"Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m\\^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.","id":"EG001","otherNumAffected":172,"otherNumAtRisk":203,"seriousNumAffected":77,"seriousNumAtRisk":203,"title":"Rituximab IV"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":104,"numAtRisk":369},{"groupId":"EG001","numAffected":54,"numAtRisk":203}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":88,"numAtRisk":369},{"groupId":"EG001","numAffected":40,"numAtRisk":203}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Ischaemic stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":369},{"groupId":"EG001","numAffected":1,"numAtRisk":203}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":369},{"groupId":"EG001","numAffected":1,"numAtRisk":203}],"term":"Transient ischaemic attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Procedural pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Non-small cell lung cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Invasive ductal breast carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Lung 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cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Prostate cancer metastatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Arterial disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Spinal osteoarthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Spondylolisthesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":369},{"groupId":"EG001","numAffected":1,"numAtRisk":203}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Haematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":369},{"groupId":"EG001","numAffected":1,"numAtRisk":203}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":369},{"groupId":"EG001","numAffected":1,"numAtRisk":203}],"term":"Cytokine release syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Eczema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":369},{"groupId":"EG001","numAffected":0,"numAtRisk":203}],"term":"Knee arthroplasty"}],"timeFrame":"Up to approximately 4.25 years"}