{"analyses":[{"ciLowerLimit":"-150.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.79","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0729","paramType":"Slope","paramValue":"-71.97","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-45.66","upperLimit":"64.55","value":"9.45"},{"groupId":"OG001","lowerLimit":"25.15","upperLimit":"137.68","value":"81.41"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"63"}],"units":"Participants"}],"description":"Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP \\<1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.","dispersionType":"95% Confidence Interval","groups":[{"description":"NEOD001, 24 mg/kg IV every 4 weeks for 12 months","id":"OG000","title":"NEOD001 24 mg/kg"},{"description":"Placebo, 0.9% Saline IV every 4 weeks for 12 months","id":"OG001","title":"Placebo"}],"paramType":"MEAN","populationDescription":"ITT population","reportingStatus":"POSTED","timeFrame":"Baseline through 12 months of treatment","title":"NT-proBNP Slope","type":"SECONDARY","unitOfMeasure":"ng/L per infusion"}