{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.53","upperLimit":"0.83","value":"0.70"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"description":"Grade 3 and 4 TEA rate was defined as the proportion of participants who experienced a grade 3 or 4 adverse event of any attribution based on NCI Common Toxicity Criteria for Adverse Events Version 4 (CTCAEv4) on treatment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.\n\n* Elotuzumab will be administered by intravenous (IV) infusion\n* Bortezomib as a subcutaneous injection\n* Lenalidomide single daily oral dose\n* Dexamethasone as oral tablets and IV infusion\n* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.\n\nSubjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.\n\nThe maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.\n\nMaintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.","id":"OG000","title":"Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone"}],"paramType":"NUMBER","populationDescription":"All participants in the safety population.","reportingStatus":"POSTED","timeFrame":"The adverse event observation period defined as the time on treatment (+30d) is 278 weeks.","title":"Grade 3 and 4 Treatment-Emergent Adverse Event (TEAE) Rate","type":"SECONDARY","unitOfMeasure":"proportion of participants"}