{"analyses":[{"ciLowerLimit":"0.879","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.554","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2861","pValueComment":"P value is from stratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"1.169","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.5","upperLimit":"12.7","value":"9.3"},{"groupId":"OG001","lowerLimit":"8.3","upperLimit":"17.9","value":"12.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"The FACT-Lym lymphoma-specific additional concerns subscale responses to all items are rated on a 5-point scale ranging from 0 \"not at all\" to 4 \"very much\". The lymphoma subscale includes 15 items and scores range from 0 to 60, with higher scores representing better functional status and well-being. A 5-point change in the Lym subscale was selected as a conservative estimate of clinically meaningful deterioration in lymphoma symptoms.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG000","title":"Randomization Phase: Ibrutinb + Venetoclax"},{"description":"Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.","id":"OG001","title":"Randomization Phase: Ibrutinib + Placebo"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"For an overall median time on study of 61.34 months (Randomization Phase)","title":"Time to Worsening in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Subscale of the Health-related Quality of Life (Randomization Phase)","type":"SECONDARY","unitOfMeasure":"months"}