{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalComment":"Probability from Wilcoxon rank sum test","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.3"},{"groupId":"OG001","value":"4.0"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43.8"},{"groupId":"OG001","value":"19.4"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29.0"},{"groupId":"OG001","value":"56.6"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.8"},{"groupId":"OG001","value":"14.3"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.1"},{"groupId":"OG001","value":"5.7"}]}],"title":"Not Evaluable (NE) those without response data"}],"denoms":[{"counts":[{"groupId":"OG000","value":"176"},{"groupId":"OG001","value":"175"}],"units":"Participants"}],"description":"Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma.","groups":[{"description":"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"},{"description":"Placebo PO daily on Days 1 to 28 of each 28 day cycle.\n\nPulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.","id":"OG001","title":"Placebo Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Intent to Treat Population includes all participants who were randomized","reportingStatus":"POSTED","timeFrame":"Randomization to 03 August 2005; up to 24 months","title":"Summary of Myeloma Response Rates Based on Best Response Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}