{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"Optimal Simon design for phase II study. p0=45% p1=65%.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.10","pValueComment":"85% statistical power","paramType":"proportion","paramValue":".57","statisticalMethod":"Simon optimal design","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"}],"units":"Participants"}],"description":"No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration.","groups":[{"description":"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.\n\nCyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.\n\nDays 2 \\& 3: Aprepitant 80 mg once daily in the morning.\n\nAprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3\n\nCyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes\n\nDexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.\n\nGranisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration.","id":"OG000","title":"Aprepitant, Dexamethasone, Cytoxan & Kytril"}],"paramType":"NUMBER","populationDescription":"Evaluable for response","reportingStatus":"POSTED","timeFrame":"at 0-24 hours","title":"Proportion of Participants With Controlled Acute Vomiting","type":"PRIMARY","unitOfMeasure":"participants"}