{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.7","upperLimit":"10.7","value":"6.5"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"6.4","value":"4.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"289"},{"groupId":"OG001","value":"289"}],"units":"Participants"}],"description":"Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ibrutinib 420 milligram (mg) (3 \\* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.","id":"OG000","title":"Ibrutinib+BR"},{"description":"Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo+BR"}],"paramType":"NUMBER","populationDescription":"ITT population included all participants randomized into the study regardless of treatment actually received.","reportingStatus":"POSTED","timeFrame":"Up to 2 years","title":"Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale","type":"SECONDARY","unitOfMeasure":"Months"}