{"analyses":[{"ciNumSides":"TWO_SIDED","dispersionType":"STANDARD_DEVIATION","dispersionValue":".05","estimateComment":"36 evaluable patients randomized 1:1 to each treatment was planned in order to have \\>77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".23","paramType":"Median Difference (Final Values)","paramValue":".05","statisticalMethod":"SAS version 8","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.36","value":"1.65"},{"groupId":"OG001","spread":"0.36","value":"2.24"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"description":"For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.","dispersionType":"Standard Deviation","groups":[{"description":"Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.","id":"OG000","title":"Arm I (Celecoxib)"},{"description":"Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.","id":"OG001","title":"Arm II (Placebo)"}],"paramType":"MEDIAN","populationDescription":"One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline and 6 months","title":"Changes in M-protein Levels","type":"PRIMARY","unitOfMeasure":"g/dL"}