{"analyses":[{"ciLowerLimit":"1.753","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.639","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","pValueComment":"Response rate was compared using Cochran-Mantel-Haenszel (CMH) chi-square test.","paramType":"Rate Ratio","paramValue":"2.526","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"76.0"},{"groupId":"OG001","value":"30.7"},{"groupId":"OG002","value":"77.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate.","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/m2 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/m2 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":"Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)","title":"Overall Response Rate (ORR) Based on IRC Assessment Up to 3 Years After Last Participant Randomized","type":"SECONDARY","unitOfMeasure":"percentage of participants"}