{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.2","upperLimit":"8.3","value":"8.1"},{"comment":"IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"195"}],"units":"Participants"}],"description":"The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.","dispersionType":"95% Confidence Interval","groups":[{"description":"An anti-CD20 monoclonal antibody\n\nofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.\n\nWeek 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)","id":"OG000","title":"Ofatumumab (Arm A)"},{"description":"A Bruton Tyrosine Kinase Inhibitor\n\nibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity","id":"OG001","title":"Ibrutinib (Arm B)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.","title":"PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013","type":"PRIMARY","unitOfMeasure":"months"}