{"analyses":[{"ciPctValue":"95","groupDescription":"With 176 evaluable participants per treatment arm, there would have been \\>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.39","statisticalMethod":"Fisher Exact","testedNonInferiority":false},{"ciPctValue":"95","groupDescription":"With 176 evaluable participants per treatment arm, there would have been \\>=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.73","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"114"},{"groupId":"OG001","value":"109"},{"groupId":"OG002","value":"106"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"54"},{"groupId":"OG002","value":"57"}]}],"title":"No"}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"163"},{"groupId":"OG002","value":"163"}],"units":"Participants"}],"description":"Hematopoietic response was defined as Hemoglobin (Hb) increment of 2.0 g/dL from baseline or achievement of Hb \\>= 11 g/dL (whichever occurs first) in the absence of red blood cell transfusions during the preceding 28 days during the treatment period.","groups":[{"description":"Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"OG000","title":"DA + IV Iron"},{"description":"Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"OG001","title":"DA + Oral Iron"},{"description":"Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.","id":"OG002","title":"DA + Placebo"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"16 Weeks","title":"Hematopoietic Response Rate Defined as the Number of Participants Who Exhibit a Hematopoietic Response","type":"PRIMARY","unitOfMeasure":"Participants"}