{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.89","value":"-5.4"},{"groupId":"OG001","spread":"30.70","value":"-4.4"},{"groupId":"OG002","spread":"30.93","value":"-7.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"446"},{"groupId":"OG001","value":"453"},{"groupId":"OG002","value":"423"}],"units":"Participants"}],"title":"Month 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.28","value":"-13.4"},{"groupId":"OG001","spread":"32.32","value":"-13.1"},{"groupId":"OG002","spread":"31.98","value":"-12.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"426"},{"groupId":"OG001","value":"423"},{"groupId":"OG002","value":"399"}],"units":"Participants"}],"title":"Month 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.64","value":"-14.4"},{"groupId":"OG001","spread":"33.44","value":"-16.1"},{"groupId":"OG002","spread":"34.45","value":"-13.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"379"},{"groupId":"OG001","value":"384"},{"groupId":"OG002","value":"355"}],"units":"Participants"}],"title":"Month 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"36.05","value":"-14.0"},{"groupId":"OG001","spread":"32.34","value":"-14.7"},{"groupId":"OG002","spread":"32.85","value":"-14.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"304"},{"groupId":"OG002","value":"255"}],"units":"Participants"}],"title":"Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.03","value":"-14.4"},{"groupId":"OG001","spread":"35.28","value":"-12.4"},{"groupId":"OG002","spread":"32.81","value":"-14.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"242"},{"groupId":"OG002","value":"183"}],"units":"Participants"}],"title":"Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"39.37","value":"-8.0"},{"groupId":"OG001","spread":"37.65","value":"-7.9"},{"groupId":"OG002","spread":"37.09","value":"-6.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"266"},{"groupId":"OG002","value":"259"}],"units":"Participants"}],"title":"Discontinuation Visit"}],"denoms":[{"counts":[{"groupId":"OG000","value":"511"},{"groupId":"OG001","value":"514"},{"groupId":"OG002","value":"512"}],"units":"Participants"}],"description":"The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.","dispersionType":"Standard Deviation","groups":[{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) administered by mouth (PO) on days 1 to 21 of each 28-day cycle plus 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone at the same schedule. Participants with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day on days 1-21 of each 28-day treatment cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle until disease progression or intolerable toxicity.","id":"OG000","title":"Lenalidomide and Low-Dose Dexamethasone (Rd)"},{"description":"Participants ≤ 75 years old received 25 mg lenalidomide (R) PO on days 1 to 21 of each 28-day treatment cycle 40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless progressive disease (PD) or intolerable toxicity occurred. Those \\> 75 years old received lenalidomide 25 mg PO on the same schedule and frequency plus 20 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Those with moderate renal insufficiency received 10-15 mg lenalidomide (R) PO on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity. Participants with severe renal insufficiency received 15 mg lenalidomide (R) PO every other day (QOD) on days 1-21 of each 28-day cycle and 20-40 mg dexamethasone (d) PO on days 1, 8, 15, and 22 of a 28-day cycle for up to 18 cycles unless PD or intolerable toxicity.","id":"OG001","title":"Lenalidomide and Dexamethasone Rd18"},{"description":"Participants received melphalan (M) 0.25 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred. Participants with moderate to severe renal insufficiency received melphalan (M) 0.10-0.125 mg/kg PO daily (QD) on days 1 to 4 of each 42-day cycle plus prednisone (P) at 2 mg/kg PO on days 1 to 4 of each 42-day cycle and thalidomide 100-200 mg PO QD on days 1 to 41 of each 42-day cycle. MPT therapy was given for up to 12 cycles unless PD or intolerable toxicity occurred.","id":"OG002","title":"Melphalan + Prednisone + Thalidomide (MPT)"}],"paramType":"MEAN","populationDescription":"Intent to Treat (ITT) population with available data.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit","title":"Change From Baseline in the EORTC QLQ-C30 Pain Domain","type":"SECONDARY","unitOfMeasure":"units on a scale"}