{"analyses":[{"ciNumSides":"TWO_SIDED","groupDescription":"With 80 patients per treatment arm, there will be\\> about 80% power to detect a difference through Fisher's exact test across two\\> treatment arms of 25% in the true percentage of patients that experience a\\> hematopoietic response as defined previously, if that percentage is at least 30% in\\> the superior group, again with a 1.7% type I error rate.","groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityComment":"If the hematopoietic response rate in the standard therapy group is far from 50% (\\<25% or \\>75%), the\\> above sample size will provide an 80% power to detect a difference as small as\\> 25%.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":">0.41","statisticalMethod":"Fisher Exact","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68.9"},{"groupId":"OG001","value":"61.7"},{"groupId":"OG002","value":"65.5"},{"groupId":"OG003","value":"66.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"57"}],"units":"Participants"}],"description":"A hematopoietic response was defined as Hb rise \\>2 g/dL from baseline or achieving Hb ≥ 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period","groups":[{"description":"Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)","id":"OG000","title":"Epoetin Alfa - 40k Weekly"},{"description":"Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)","id":"OG001","title":"Epoetin Alfa - 80k Every 3 Weeks"},{"description":"Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)","id":"OG002","title":"Epoetin Alfa - 120k Every 3 Weeks"},{"description":"Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)","id":"OG003","title":"Darbepoetin Alfa - 500 mcg Every 3 Weeks"}],"paramType":"NUMBER","populationDescription":"All patients that were evaluable per protocol.","reportingStatus":"POSTED","timeFrame":"20 weeks","title":"The Percentage of Participants Who Exhibit a Hematopoietic Response","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}