{"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":">0.56","statisticalMethod":"Fisher Exact","testedNonInferiority":true}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"60"},{"groupId":"OG002","value":"58"},{"groupId":"OG003","value":"55"}],"units":"Participants"}],"description":"To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Adverse events were measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.","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 and reported at least one value after baseline.","reportingStatus":"POSTED","timeFrame":"16 weeks","title":"The Percentage of Participants Reported Grade 3 or 4 Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}