{"analyses":[{"ciLowerLimit":"1.013","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.250","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0273","paramType":"Rate Ratio","paramValue":"1.125","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"91.2"},{"groupId":"OG001","value":"81.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"description":"ORR, defined as the percentage of participants achieving a best overall response of protocol-specified CR, CRi, nPR or PR per investigator assessment at or prior to initiation of subsequent antineoplastic therapy. Assessment of response included physical examination, radiographic imaging, and evaluation of blood and marrow (if applicable), evaluated in accordance with the IWCLL 2008 criteria (Halleck et al). CR, CRi, nPR, and PR required confirmation with 2 consecutive assessments that were at least 56 days apart and no use of blood supportive product and/or growth factor during this period. Kaplan-Meier estimate.","groups":[{"description":"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.","id":"OG000","title":"IBR+OB"},{"description":"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.","id":"OG001","title":"CLB+OB"}],"paramType":"NUMBER","populationDescription":"Intent to Treat population: all randomized participants","reportingStatus":"POSTED","timeFrame":"Median follow-up time was 44.6 months at the time of the final analysis (data cutoff date: 17 October 2019).","title":"Final Analysis: ORR Based on Investigator Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}