{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value calculation excludes the category - Response not evaluable (NE)","statisticalMethod":"Wilcoxon (Mann-Whitney)","testedNonInferiority":false},{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.009","pValueComment":"P-value calculation excludes the category - Response not evaluable (NE)","statisticalMethod":"Wilcoxon (Mann-Whitney)","testedNonInferiority":false},{"ciPctValue":"95","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"P-value calculation excludes the category - Response not evaluable (NE)","statisticalMethod":"Wilcoxon (Mann-Whitney)","testedNonInferiority":false},{"ciLowerLimit":"2.04","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.47","groupDescription":"Based on dichotomized response: 1) CR or PR 2) SD or PD or NE","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Odds Ratio (OR)","paramValue":"3.34","statisticalMethod":"Fisher Exact","testedNonInferiority":false},{"ciLowerLimit":"0.95","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.62","groupDescription":"Based on dichotomized response: 1) CR or PR 2) SD or PD or NE","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.096","paramType":"Odds Ratio (OR)","paramValue":"1.58","statisticalMethod":"Fisher Exact","testedNonInferiority":false},{"ciLowerLimit":"1.33","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.37","groupDescription":"Based on dichotomized response: 1) CR or PR 2) SD or PD or NE","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","paramType":"Odds Ratio (OR)","paramValue":"2.12","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"title":"Complete response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"102"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"72"}]}],"title":"Partial response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"70"}]}],"title":"Stable disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Progressive disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"}]}],"title":"Response not evaluable (NE)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"153"},{"groupId":"OG002","value":"154"}],"units":"Participants"}],"description":"Data as of 11 May 2010 cutoff. Best response was determined by the Central Assessment Committee (CAC) based on the European Group for Blood and Marrow Transplantation (EBMT) criteria: Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of bone lesions, plus other factors); Partial Response (PR)-not all CR criteria, plus \\>=50% reduction in serum monoclonal paraprotein plus others; Stable Disease (SD)- not PR or PD; Progressive Disease (PD)- reappearance of monoclonal paraprotein, bone lesions, other; Not Evaluable (NE).","groups":[{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG000","title":"MPR+R"},{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG001","title":"MPR+p"},{"description":"Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG002","title":"MPp+p"}],"paramType":"NUMBER","populationDescription":"Intent to treat population","reportingStatus":"POSTED","timeFrame":"Up to 165 weeks","title":"Number of Participants in Disease Response Categories Representing Their Best Response During the Double-blind Treatment Period","type":"SECONDARY","unitOfMeasure":"participants"}