{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.9","upperLimit":"45.46","value":"32.75"},{"groupId":"OG001","lowerLimit":"28.58","upperLimit":"45.89","value":"37.24"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact. This analysis is only based on the FS score. Items are scored on a 5 point Likert-type scale. Item scores can range from 0 (\"not at all\") to 4 (\"very much\"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue. The recall period for each item is the past 7 days. Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.","dispersionType":"Full Range","groups":[{"description":"Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles.\n\nClarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle.\n\nLenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle\n\nDexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.","id":"OG000","title":"BiRD Treatment Regimen"},{"description":"Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles.\n\nLenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle\n\nDexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.","id":"OG001","title":"Rd Treatment Regimen"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"up to 3 years","title":"Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment","type":"SECONDARY","unitOfMeasure":"Score on a scale"}