{"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 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.62","statisticalMethod":"t-test, 2 sided","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 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.30","statisticalMethod":"t-test, 2 sided","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.73","value":"6.0"},{"groupId":"OG001","spread":"11.54","value":"3.5"},{"groupId":"OG002","spread":"10.50","value":"5.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"163"},{"groupId":"OG002","value":"163"}],"units":"Participants"}],"description":"SDS Scale range: 0 (Worst), 100 (Best), ordinal. Change: score at 16 weeks minus score at baseline. A clinically significant result will be defined as a shift of 10 points on a 0-100 point transformed scale between the average QOL scores of the 3 variants of iron therapy.","dispersionType":"Standard Deviation","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":"MEAN","reportingStatus":"POSTED","timeFrame":"Baseline and 16 weeks","title":"Change From Baseline in Quality of Life (QOL) Score as Measured by Symptom Distress Scale (SDS) at End of Study","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}