{"analyses":[{"ciLowerLimit":"0.92","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"42.48","groupDescription":"Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".07","paramType":"Hazard Ratio (HR)","paramValue":"6.27","statisticalComment":"Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.","statisticalMethod":"Gray"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"description":"The number of participants dead due to causes unrelated to relapse within the first 100 days post transplant.","groups":[{"description":"Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40 mg/m\\^2 I.V. over 1 hour","id":"OG000","title":"AUC 6000"},{"description":"Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40 mg/m\\^2 I.V. over 1 hour","id":"OG001","title":"AUC 7500"},{"description":"Busulfan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40 mg/m\\^2 I.V. over 1 hour","id":"OG002","title":"AUC 9000"}],"paramType":"NUMBER","populationDescription":"Intent to treat","reportingStatus":"POSTED","timeFrame":"100 days","title":"Non-relapse Mortality","type":"PRIMARY","unitOfMeasure":"participants"}