{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"586"}]}],"title":"At least one treatment-emergent AE (TEAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"519"}]}],"title":"At least one TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"471"}]}],"title":"At least one TEAE with severity grade of 3 or 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"340"}]}],"title":"At least one serious AE (SAE)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"587"}],"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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"up to 123 weeks","title":"Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment","type":"PRIMARY","unitOfMeasure":"participants"}