{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"139"}]}],"title":">=1 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"119"}]}],"title":">=1 TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"105"}]}],"title":">=1 NCI CTCAE grade 3 or 4 TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"}]}],"title":">=1 NCI CTCAE grade 3 or 4 TEAE related to drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79"}]}],"title":">=1 serious AE (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"}]}],"title":">=1 study drug related SAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}],"title":"Discontinued due to TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"}]}],"title":"Discontinued due to TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}],"title":"TEAE leading to dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"64"}]}],"title":"TEAE leading to dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79"}]}],"title":"Deaths"}],"denoms":[{"counts":[{"groupId":"OG000","value":"144"}],"units":"Participants"}],"description":"Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category.\n\nNational Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.","groups":[{"description":"Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"up to 8 months","title":"Participants With Treatment-emergent Adverse Experiences (TEAEs)","type":"SECONDARY","unitOfMeasure":"participants"}