{"description":"Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":81,"description":"Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.\n\nPegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.\n\nRituximab: 375 mg/m\\^2/day on Days 1, 4, 8, 11, 45, and 52.\n\nCyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.","id":"EG000","otherNumAffected":64,"otherNumAtRisk":81,"seriousNumAffected":15,"seriousNumAtRisk":81,"title":"R-HiCy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":81,"numEvents":18}],"term":"ALT high"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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(3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":81,"numEvents":6}],"term":"Pain - hip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":81,"numEvents":10}],"term":"Pain - mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":81,"numEvents":26}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":81,"numEvents":6}],"term":"Rigors"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":81,"numEvents":4}],"term":"Diaphoresis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":81,"numEvents":8}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":81,"numEvents":100}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":81,"numEvents":14}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":81,"numEvents":40}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":81,"numEvents":4}],"term":"Weight gain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Atrial fibrillation with rapid ventricular response"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":81,"numEvents":2}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Infection (unspecified)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Lipase elevated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Pain - wrist"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Secondary malignancy - acute myeloid leukemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":81,"numEvents":1}],"term":"Syncope"}],"timeFrame":"Up to 1 year"}