{"description":"The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade toxicities for patients","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Cohort A: Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Cohort A"},{"deathsNumAffected":10,"deathsNumAtRisk":13,"description":"Cohort B: Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"EG001","otherNumAffected":10,"otherNumAtRisk":13,"seriousNumAffected":5,"seriousNumAtRisk":13,"title":"Cohort B"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":13,"numEvents":4}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":13,"numEvents":4}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 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4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 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4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"noninfective","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1}],"term":"Neoplasms benign"}]}