{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"5"},{"groupId":"OG004","value":"3"}]}],"title":"Any reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Grade 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"2"}]}],"title":"Grade 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"36"},{"groupId":"OG004","value":"37"}],"units":"Participants"}],"description":"During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).","groups":[{"description":"Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.","id":"OG000","title":"Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)"},{"description":"Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.","id":"OG001","title":"Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)"},{"description":"Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.","id":"OG002","title":"Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)"},{"description":"Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.","id":"OG003","title":"Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)"},{"description":"Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.","id":"OG004","title":"Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)"}],"paramType":"NUMBER","populationDescription":"Safety population: All randomized participants who received at least 1 dose of study drug","reportingStatus":"POSTED","timeFrame":"Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)","title":"Number of Participants With Infusion Reactions","type":"SECONDARY","unitOfMeasure":"participants"}