{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"}],"units":"Participants"}],"description":"For the Phase II study portion, to determine the efficacy (measured as response rate) of the combination therapy as defined by the International Working Group (IWG) criteria (CR, complete remission; PR, partial remission; or HI, hematological improvement.\n\nComplete response (CR) is defined as: Disappearance of the chromosomal abnormality without appearance of new ones.\n\nPartial response (PR) is defined as: At least 50% reduction of the chromosomal abnormality.\n\nHematologic Improvement (HI) is defined as: red blood cell increase of \\>=1.5g/dL, a platelet response of \\>=30X10\\^9/L or by at least 100% for values starting \\<20X10\\^9/L, or a neutrophil response of at least 100% and absolute increase of \\>0.5X10\\^9/L","groups":[{"description":"azacitidine: Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.\n\nlenalidomide: Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.","id":"OG000","title":"Lenalidomide and Azacitidine"}],"paramType":"NUMBER","populationDescription":"Intention to Treat","reportingStatus":"POSTED","timeFrame":"After 4 courses (4 months)","title":"PHASE II: Determine the Number of Patients With Responses for Efficacy(Measured as Response Rate)","type":"PRIMARY","unitOfMeasure":"participants"}