{"description":"Medical history and physical before treatment, Days 1, 5 and 22 of the 1st cycle and before cycles 2 and 3, before ALI. Blood for study specific tests drawn before ALI and 2, 4 and 8 weeks after and if relapse occurs. Chest x ray before ALI. Bone marrow Biopsy at baseline and after cycle 3.","eventGroups":[{"description":"azacitidine: 75 mg/sq m daily for 5 days\n\nlenalidomide: 10 mg p.o. daily, Days 6-21","id":"EG000","otherNumAffected":12,"otherNumAtRisk":17,"seriousNumAffected":9,"seriousNumAtRisk":17,"title":"5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":3}],"term":"Low Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":17,"numEvents":27}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":4}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":4}],"term":"High Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"High AST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2-3.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"High ALT"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization. Received radiation therapy with improvement. Grade 3: Severe pain; pain or analgesics severely interfering with ADL.","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Pain - Pack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization, disease progression and death occurred after 100 days. Grade 5, death.","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization. Grade 3, Severe pain; pain or analgesics severely interfering with ADL.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Pain - Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3, Symptomatic, interfering with ADL; O2 indicated.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization.","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Neurology, Grade 2: Mild mood alteration not interfering with function .","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Mood alteration - Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":17,"numEvents":2}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils - blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Neurology. Hospitalization.","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Mental Status"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hospitalization. Grade 3: Requiring more than one drug or more intensive therapy than previously.","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE VERSION 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":17,"numEvents":1}],"term":"Hypertension"}],"timeFrame":"1 year the subject will be on study and evaluated for adverse events."}