{"description":"AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.\n\nPer protocol, AEs were not collected during ASCT (stem cell collection through start of consolidation) and during single-agent lenalidomide maintenance.","eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":76,"description":"INDUCTION THERAPY: Patients receive dexamethasone IV or PO QD on days 1, 8, 15 and 22; carfilzomib IV over 10-30 minutes on days 1, 2, 8, 9, 15, and 16; and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity..\n\nTRANSPLANT: Patients undergo autologous stem cell transplant.\n\nCONSOLIDATION THERAPY: Patients receive dexamethasone, carfilzomib, and lenalidomide as in induction. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nMAINTENANCE THERAPY: Patients receive dexamethasone and lenalidomide as in induction therapy and carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Treatment repeats every 28 days for 10 courses in the absence of disease progression or unacceptable toxicity.\n\ndexamethasone: Given IV or PO\n\ncarfilzomib: Given IV\n\nlenalidomide: Given PO\n\nautologous hematopoietic stem cell transplantation: Undergo autologous hematopoietic stem cell transplant\n\nlaboratory biomarker analysis: Correlative studies","id":"EG000","otherNumAffected":76,"otherNumAtRisk":76,"seriousNumAffected":27,"seriousNumAtRisk":76,"title":"Treatment (Dexamethasone, Carfilzomib, Lenalidomide)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":76,"numEvents":15}],"term":"Cardiac disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":76,"numEvents":15}],"term":"Thromboembolic events"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":76,"numEvents":23}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":76,"numEvents":49}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":76,"numEvents":62}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":76,"numEvents":41}],"term":"Peripheral neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":76,"numEvents":47}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":76,"numEvents":79}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":76,"numEvents":67}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":76,"numEvents":111}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":76,"numEvents":136}],"term":"Infection"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"NCI V4.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":76,"numEvents":54}],"term":"serious cardiovascular events"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":76,"numEvents":10}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":76,"numEvents":4}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Non-cardiac chest pain, pleuritic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Eye disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Gastrointestinal disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":76,"numEvents":3}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Infections and infestations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Joint infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Musculoskeletal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Burkitt lymphoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Treatment related secondary malignancy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Seizure, tonic clonic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Nervous system disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Agitation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"shingles outbreak near port-a-cath site"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":76,"numEvents":4}],"term":"Thromboembolic Event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":2}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Skin and subcutaneous disorders"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Enterocolitis Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"ALT Elevation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"NCI V4.01","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":76,"numEvents":1}],"term":"Cytokine Release Syndrome"}],"timeFrame":"adverse events (AEs) were collected from the day of treatment initiation through 30 days post-last dose or at the initiation of a new anticancer therapy, up to 5 years."}