{"analyses":[{"ciLowerLimit":"-13.98","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.09","estimateComment":"Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.","groupDescription":"The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"LS Mean Difference","paramValue":"-5.94","statisticalMethod":"ANCOVA","testedNonInferiority":true},{"ciLowerLimit":"-9.73","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.96","estimateComment":"Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.","groupDescription":"The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.","groupIds":["OG000","OG002"],"nonInferiorityComment":"The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"LS Mean Difference","paramValue":"-1.39","statisticalMethod":"ANCOVA","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.906","value":"2.92"},{"groupId":"OG001","spread":"2.872","value":"-3.03"},{"groupId":"OG002","spread":"3.086","value":"1.53"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"57"}],"units":"Participants"}],"description":"Detrusor pressure at maximum urinary flow rate (PdetQmax) was measured by the Investigator using cystometry and was sent to an independent central reading center for review and interpretation.\n\nLeast squares means (LSM) were derived from an analysis of covariance (ANCOVA) model with the pooled study center and treatment as factors and the baseline value as a covariate.","dispersionType":"Standard Error","groups":[{"description":"Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.","id":"OG000","title":"Placebo"},{"description":"Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.","id":"OG001","title":"Mirabegron 50 mg"},{"description":"Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.","id":"OG002","title":"Mirabegron 100 mg"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"The Full Analysis Set included all patients who received at least 1 dose of double-blind study drug \\& had both Qmax \\& PdetQmax measurements at Baseline \\& 1 or both at any postbaseline on-treatment visit. Data include the last on-treatment assessment for patients who did not complete the Week 12 visit.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 12","title":"Change From Baseline to End of Treatment in Detrusor Pressure at Maximum Flow Rate (PdetQmax)","type":"PRIMARY","unitOfMeasure":"cmH2O"}