{"groups":[{"description":"Patients receive lenalidomide PO QD on days 1-21.","id":"FG000","title":"Arm A (Lenalidomide; Chromosome 5q31.1 Deletion)"},{"description":"Patients receive lenalidomide PO QD on days 1-21.","id":"FG001","title":"Arm A (Lenalidomide; Randomization)"},{"description":"Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.","id":"FG002","title":"Arm B (Lenalidomide + Epoetin Alfa; Randomization)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"21"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"20"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Patient and physician's decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}],"type":"Other complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Alternative therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient switched treatment early due to DSMC announcement"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}],"type":"Off treatment reason unknown"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Never started treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"103"},{"groupId":"FG002","numSubjects":"106"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"103"},{"groupId":"FG002","numSubjects":"106"}],"type":"Treated Patients"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"96"},{"groupId":"FG002","numSubjects":"99"}],"type":"Evaluable Patients Included in Primary Analysis"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"51"}],"type":"Patients With Cytogenetic Response Data Available"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"48"},{"groupId":"FG002","numSubjects":"41"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"55"},{"groupId":"FG002","numSubjects":"65"}],"type":"NOT COMPLETED"}],"title":"Step 1"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Alternative treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Prolonged wound healing"}],"milestones":[{"achievements":[{"comment":"All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.","groupId":"FG000","numSubjects":"7"},{"comment":"All patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.","groupId":"FG001","numSubjects":"46"},{"comment":"Only patients in Arm A that did not achieve major erythroid response (MER) were offered to receive combined treatment in Step 2.","groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"0"}],"type":"Evaluable Patients Included in Primary Analysis"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Step 2 (Cross-over to Arm B)"}],"recruitmentDetails":"From April 2009 through May 2016, the trial enrolled a total of 247 patients."}