{"analyses":[{"ciLowerLimit":"0.955","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.603","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1059","pValueComment":"CMH chi squared test","paramType":"Rate Ratio","paramValue":"1.238","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68.0"},{"groupId":"OG001","value":"54.7"},{"groupId":"OG002","value":"87.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"Percentage of participants with ≥ 3 points increase from baseline by Week 25 in the FACIT-Fatigue subscale score.The FACIT-Fatigue is a 13-item questionnaire that assesses participant reported fatigue and its impact upon daily activities and function over the past 7 days. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total scores from 0 (extreme fatigue) to 52 (no fatigue). Scores below 30 indicate severe fatigue.","groups":[{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"OG000","title":"Ibrutinib + Rituximab"},{"description":"Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment.\n\nRituximab: 375 mg/m\\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.","id":"OG001","title":"Placebo + Rituximab"},{"description":"Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.","id":"OG002","title":"Open-Label Substudy: Ibrutinib"}],"paramType":"NUMBER","populationDescription":"Intent to Treat population: all randomized/enrolled participants","reportingStatus":"POSTED","timeFrame":"Baseline, 25 weeks","title":"Percentage of Participants With ≥ 3 Points Increase From Baseline by Week 25 in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Subscale Score","type":"SECONDARY","unitOfMeasure":"percentage of participants"}