{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.85","value":"2.3"},{"groupId":"OG001","spread":"24.06","value":"1.9"},{"groupId":"OG002","spread":"25.65","value":"3.2"}]}],"title":"Cycle 4 - approximately Month 4 (n=115,125,124)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.54","value":"3.4"},{"groupId":"OG001","spread":"23.09","value":"-1.2"},{"groupId":"OG002","spread":"22.13","value":"0.9"}]}],"title":"Cycle 7 - approximately Month 7 (n=98,109,112)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.98","value":"1.1"},{"groupId":"OG001","spread":"20.91","value":"1.4"},{"groupId":"OG002","spread":"21.19","value":"-0.0"}]}],"title":"Cycle 10 - approximately Month 10 (n=87,92,95)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.43","value":"5.5"},{"groupId":"OG001","spread":"18.78","value":"-1.4"},{"groupId":"OG002","spread":"18.35","value":"0.8"}]}],"title":"Cycle 13 - approximately Month 13 (n=73,73,80)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.83","value":"10.6"},{"groupId":"OG001","spread":"19.75","value":"1.3"},{"groupId":"OG002","spread":"17.74","value":"0.5"}]}],"title":"Cycle 16 - approximately Month 16 (n=63,52,61)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"152"},{"groupId":"OG001","value":"153"},{"groupId":"OG002","value":"154"}],"units":"Participants"}],"description":"Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.","dispersionType":"Standard Deviation","groups":[{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG000","title":"MPR+R"},{"description":"Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG001","title":"MPR+p"},{"description":"Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.","id":"OG002","title":"MPp+p"}],"paramType":"MEAN","populationDescription":"Intent to treat population","reportingStatus":"POSTED","timeFrame":"Baseline (Day 0), Months 4, 7, 10, 13, 16","title":"Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhoea Scale","type":"SECONDARY","unitOfMeasure":"units on a scale"}