{"analyses":[{"ciLowerLimit":"0.291","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.863","estimateComment":"The HR and 95% CI were estimated from a stratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.011","pValueComment":"The 2-sided nominal p-value was calculated based on a stratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.501","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"141"},{"groupId":"OG001","value":"141"}],"units":"Participants"}],"description":"A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.","id":"OG000","title":"Arm A - Pirtobrutinib"},{"description":"Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).","id":"OG001","title":"Arm B - Bendamustine Plus Rituximab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization up to 37 months","title":"Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58","type":"SECONDARY","unitOfMeasure":"Months"}