{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1","pValueComment":"baseline, 3 month","statisticalMethod":"paired t-test"},{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.09","statisticalComment":"baseline, month 5","statisticalMethod":"paired t-test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.1","value":"51.7"}]}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"66.7"}]}],"title":"3 months"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.9","value":"66.7"}]}],"title":"5 months"}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week?\n\n7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.","dispersionType":"Standard Deviation","groups":[{"description":"INDUCTION (28-day cycles for 8 cycles):\n\n* VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15\n* Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15\n* Dexamethasone 40 mg PO days 1,8 and 15\n\nMAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):\n\n* Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21\n* Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15\n\nVelcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \\[10,12,14, etc.\\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until","id":"OG000","title":"Velcade, Cyclophosphamide, Revlimid"}],"paramType":"MEAN","populationDescription":"Participants who completed questionnaire.","reportingStatus":"POSTED","timeFrame":"baseline, 3 months, 5 months","title":"QLQ-C30 Question 30","type":"SECONDARY","unitOfMeasure":"units on a scale"}