{"eventGroups":[{"description":"Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.","id":"EG000","otherNumAffected":36,"otherNumAtRisk":500,"seriousNumAffected":23,"seriousNumAtRisk":500,"title":"Arm I: Induction Rituximab"},{"description":"Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.","id":"EG001","otherNumAffected":5,"otherNumAtRisk":169,"seriousNumAffected":5,"seriousNumAtRisk":169,"title":"Arm A: Rituximab Retreatment"},{"description":"Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.","id":"EG002","otherNumAffected":14,"otherNumAtRisk":177,"seriousNumAffected":10,"seriousNumAtRisk":177,"title":"Arm B: Rituximab Scheduled"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":500},{"groupId":"EG001","numAffected":5,"numAtRisk":169},{"groupId":"EG002","numAffected":14,"numAtRisk":177}],"term":"Fatigue"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Anaphylaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":500},{"groupId":"EG001","numAffected":2,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":1,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":1,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":500},{"groupId":"EG001","numAffected":1,"numAtRisk":169},{"groupId":"EG002","numAffected":3,"numAtRisk":177}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Peripheral nerve infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Infections and infestations - Other, spe"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":1,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":1,"numAtRisk":177}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Respiratory, thoracic and mediastinal di"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":500},{"groupId":"EG001","numAffected":0,"numAtRisk":169},{"groupId":"EG002","numAffected":0,"numAtRisk":177}],"term":"Cytokine release syndrome"}],"timeFrame":"Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years"}