{"description":"Adverse events were reported for 40 unique patients treated at dose levels 1-3 and 16 patients treated at Dose level 4","eventGroups":[{"description":"Dose Level 1: Patients were administered Flavopiridol 30mg/m2 bolus followed by 30 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles\n\nDose Level 2: Patients were administered Flavopiridol 40mg/m2 bolus followed by 40 mg/m2 4 hour infusion weekly for four weeks followed by two weeks without therapy for a total of 6 cycles\n\nDose Level 3: Patients were administered Flavopiridol dose level one scheduled for the first cycle. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles","id":"EG000","otherNumAffected":40,"otherNumAtRisk":40,"seriousNumAffected":11,"seriousNumAtRisk":42,"title":"Dose Levels 1-3"},{"description":"Dose Level 4: Patients were administered Flavopiridol dose level one scheduled for the first dose. In absence of severe toxicity, dose level was escalated to 30mg/m2 bolus followed by 50 mg/m2 4 hour infusion for a total of 6 cycles","id":"EG001","otherNumAffected":16,"otherNumAtRisk":16,"seriousNumAffected":1,"seriousNumAtRisk":16,"title":"Dose Level 4"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":40,"numEvents":30},{"groupId":"EG001","numAffected":16,"numAtRisk":16,"numEvents":16}],"term":"Absolute Neutrophil Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":40,"numEvents":0},{"groupId":"EG001","numAffected":11,"numAtRisk":16,"numEvents":11}],"term":"WBC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":40,"numEvents":15},{"groupId":"EG001","numAffected":7,"numAtRisk":16,"numEvents":7}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hemorhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":40,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":16,"numEvents":3}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":40,"numEvents":16},{"groupId":"EG001","numAffected":12,"numAtRisk":16,"numEvents":12}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Abdominal pain/cramping"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":40,"numEvents":13},{"groupId":"EG001","numAffected":3,"numAtRisk":16,"numEvents":3}],"term":"AST SGOT(serum glutamic oxaloacetic transaminase) or ALT, SGPT (serum glutamic pyruvic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Bilirubin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Renal Failture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":16,"numEvents":4}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":16,"numEvents":6}],"term":"Infection w/neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40,"numEvents":8},{"groupId":"EG001","numAffected":2,"numAtRisk":16,"numEvents":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 2.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":40,"numEvents":23},{"groupId":"EG001","numAffected":7,"numAtRisk":16,"numEvents":7}],"term":"Biochemical tumor lysis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 2.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":42,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":16,"numEvents":1}],"term":"Hyperacute Tumor Lysis"}],"timeFrame":"Patients were assessed for toxicities from Day 1 of each Flavopiridol Treatment to Post-Treatment Follow-up. Follow up was performed every 3 months for 2 years."}