{"analyses":[{"ciLowerLimit":"74.269","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"100","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.","paramType":"Overall dichotomized response rate","paramValue":"87.5","statisticalMethod":"Binomial test for dichotomized response"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"87.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.\n\nCR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \\< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \\< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.","groups":[{"description":"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.\n\nDexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.","id":"OG000","title":"Lenalidomide Plus Dexamethasone"}],"paramType":"NUMBER","populationDescription":"Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.","title":"Overall Response Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}