{"eventGroups":[{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.","id":"EG000","otherNumAffected":523,"otherNumAtRisk":532,"seriousNumAffected":378,"seriousNumAtRisk":532,"title":"Lenalidomide and Low-Dose Dexamethasone (Rd)"},{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.","id":"EG001","otherNumAffected":532,"otherNumAtRisk":540,"seriousNumAffected":308,"seriousNumAtRisk":540,"title":"Lenalidomide and Dexamethasone (Rd18)"},{"description":"Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.","id":"EG002","otherNumAffected":532,"otherNumAtRisk":541,"seriousNumAffected":270,"seriousNumAtRisk":541,"title":"Melphalan + Prednisone + Thalidomide (MPT)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA15.1","stats":[{"groupId":"EG000","numAffected":237,"numAtRisk":532},{"groupId":"EG001","numAffected":191,"numAtRisk":540},{"groupId":"EG002","numAffected":219,"numAtRisk":541}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA15.1","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":532},{"groupId":"EG001","numAffected":59,"numAtRisk":540},{"groupId":"EG002","numAffected":92,"numAtRisk":541}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic 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disorders","sourceVocabulary":"MEDDRA15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":532},{"groupId":"EG001","numAffected":0,"numAtRisk":540},{"groupId":"EG002","numAffected":1,"numAtRisk":541}],"term":"THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MEDDRA15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":532},{"groupId":"EG001","numAffected":0,"numAtRisk":540},{"groupId":"EG002","numAffected":1,"numAtRisk":541}],"term":"VENOUS THROMBOSIS"}],"timeFrame":"From the first dose of treatment to at least 28 days after discontinuation of active treatment for those not continuing in the PFS phase; median duration of treatment was 80.2 weeks in the Rd arm, 72.0 weeks in the Rd18 arm and 67.1 weeks in the MPT arm."}