{"description":"NCI Common Toxicity Criteria for Adverse Events (version 3.0) was used to define and grade toxicity.","eventGroups":[{"description":"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.\n\nPHASE II: Patients receive flavopiridol\\* as in phase I at the MTD determined in phase I.\n\nalvocidib: Given IV","id":"EG000","otherNumAffected":34,"otherNumAtRisk":35,"seriousNumAffected":0,"seriousNumAtRisk":35,"title":"Treatment (Alvocidib)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":35,"numEvents":30}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":35,"numEvents":34}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":35,"numEvents":25}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":35,"numEvents":22}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":35,"numEvents":13}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":35,"numEvents":9}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"Neutropenia fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35,"numEvents":12}],"term":"Increased ALT/AST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":35,"numEvents":6}],"term":"Hyperbilirubinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":35,"numEvents":12}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":35,"numEvents":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35,"numEvents":8}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":35,"numEvents":27}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35,"numEvents":8}],"term":"Tumor Lysis Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":35,"numEvents":8}],"term":"Cytokine Release Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 3.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":35,"numEvents":21}],"term":"Fatigue"}],"timeFrame":"Patients were assessed for clinical response after two, four and six cycles with laboratory studies, physical exam, and CT scans."}