{"analyses":[{"ciLowerLimit":"0.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.0","groupDescription":"The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.","groupIds":["OG000"],"nonInferiorityComment":"The non-inferiority margin was 2 days.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.025","paramType":"Median Difference (Final Values)","paramValue":"0","statisticalMethod":"Hodges-Lehman estimation","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-1","upperLimit":"2","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"description":"Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease.\n\nAs this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D \\> \\|2\\|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery.","dispersionType":"Full Range","groups":[{"description":"Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.","id":"OG000","title":"Patients With Multiple Myeloma"}],"paramType":"MEDIAN","populationDescription":"Twenty-six patients were evaluable per protocol.","reportingStatus":"POSTED","timeFrame":"up to 28 days following transplant","title":"Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.","type":"PRIMARY","unitOfMeasure":"Days"}