{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}],"title":"Neutropenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Thrombocytopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Lymphopenia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Infection-Upper respiratory"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"}]}],"title":"Infection-Non-pulmonary"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Infection-Lung"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Infection-Bronchial"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}],"title":"Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Peripheral neuropathy"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}],"title":"Hyperglycemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Cardia events, any"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Electrolyte imbalances, any"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Hypertension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"}]}],"title":"Rash"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Thromboembolic events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Infusion reactions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Acute kidney injury"}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"}],"units":"Participants"}],"description":"AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)","groups":[{"description":"Subjects will be tested for Minimal Residual Disease (MRD) by Next Generation Sequencing (NGS) and flow cytometry after cycles 8 and 12. A treatment decision was made after cycle 12 based on these results. There are three outcomes based on the IFM trial (Avet-Loiseau et al., 2015): 1) if the subject is MRD-negative by NGS after cycle 8 and 12, the subject went on E-Rd maintenance until disease progression. 2) If the subject is MRD-positive after cycle 8 but MRD-negative after cycle 12, 6 more cycles of E-KRd was given and at the end of 18 cycles, the subject went on E-Rd maintenance until disease progression. 3) Finally, if the subject is MRD-positive at both instances, 12 additional cycles of E-KRd was given and at the end of 24 cycles total, the subject went on E-Rd maintenance until disease progression.\n\nElotuzumab: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15\n\nCarfilzomib: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond\n\nLenalidomide: Lenalidomide will be given on days 1-21 for all cycles.\n\nDexamethasone: Dexamethasone will be given as follows:\n\nCycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22","id":"OG000","title":"Elo-KRd Regimen"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"AEs were recorded from the day of signed consent through 30 days after the last does of Elo-KRd or initiation of new therapy, an average of 2 years.","title":"Number of Participants With Adverse Events of Elotuzumab in Combination With KRd","type":"SECONDARY","unitOfMeasure":"Participants"}