{"description":"Adverse events categorized based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":16,"description":"Patients with baseline platelet counts \\>50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts \\> 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count \\>50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were \\>50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses.\n\nTreatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nEltrombopag Olamine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLenalidomide: Given PO","id":"EG000","otherNumAffected":15,"otherNumAtRisk":16,"seriousNumAffected":8,"seriousNumAtRisk":16,"title":"Arm A (Platelets > 50,000 k/uL) LEN Initiation"},{"deathsNumAffected":2,"deathsNumAtRisk":15,"description":"Patients with baseline platelet counts \\<50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count \\>50,000 k/uL was achieved. Once a platelet count\\>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \\>10.0 g/dL and didn't decrease while on study drug.\n\nTreatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nEltrombopag Olamine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLenalidomide: Given PO Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nEltrombopag Olamine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies\n\nLenalidomide: Given PO","id":"EG001","otherNumAffected":9,"otherNumAtRisk":15,"seriousNumAffected":5,"seriousNumAtRisk":15,"title":"Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination"},{"deathsNumAffected":0,"deathsNumAtRisk":21,"description":"Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \\>10.0 g/dL and didn't decrease while on study drug.\n\nTreatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nEltrombopag Olamine: Given PO\n\nLaboratory Biomarker Analysis: Correlative studies","id":"EG002","otherNumAffected":4,"otherNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"title":"Arm C (Platelets < 50,000 k/uL) ELT Monotherapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperbilirubinemia from development of bone marrow fibrosis","organSystem":"Investigations","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":15,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Blood Bilirubin Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"AST/ALT elevation, reversible increase in peripheral blasts","organSystem":"Investigations","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Acute Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Right Arm Hematoma","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":21,"numEvents":1}],"term":"Upper Gastrointestinal Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":16,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16,"numEvents":2},{"groupId":"EG001","numAffected":6,"numAtRisk":15,"numEvents":6},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Acute Kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Arthralgia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":16,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":15,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Severe thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":16,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Thrombocytopenia (severe)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":16,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":15,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (Version 5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":16,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":15,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0}],"term":"Gall Bladder Cancer"}],"timeFrame":"Through study completion, up to 2 years"}