{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.61","estimateComment":"Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","paramType":"Hazard Ratio (HR)","paramValue":"0.49","statisticalComment":"Stratified by age, disease population, and prior number of anti myeloma therapy.","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.0","upperLimit":"19.6","value":"16.0"},{"groupId":"OG001","lowerLimit":"7.1","upperLimit":"9.4","value":"8.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"302"},{"groupId":"OG001","value":"153"}],"units":"Participants"}],"description":"Progression-free survival was calculated as the time from randomization to disease progression as determined by the Independent Response Adjudication Committee based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: • Increase of ≥ 25% from nadir in: o Serum M-component (absolute increase ≥ 0.5 g/dl); o Urine M-component (absolute increase ≥ 200 mg/24 hours); o Bone marrow plasma cell percentage (absolute % ≥ 10%); • Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; • Development of hypercalcemia (corrected serum calcium \\> 11.5 mg/dl) attributed solely to plasma cell proliferative disease.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.","id":"OG000","title":"Pomalidomide Plus Low-Dose Dexamethasone"},{"description":"Participants received 40 mg dexamethasone (participants \\> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.","id":"OG001","title":"High-Dose Dexamethasone"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 01 March 2013. Maximum duration of follow-up for PFS assessments was 74 weeks.","title":"Progression-free Survival (PFS) With a Later Cut-off Date","type":"PRIMARY","unitOfMeasure":"weeks"}