{"analyses":[{"ciLowerLimit":"0.09","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.28","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.16","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"IBR: Median PFS was not reached so 95% CI for median PFS is not applicable.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"14.1","upperLimit":"22.0","value":"18.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS\n\nProgressive disease according to 2008 IWCLL guidelines was defined as:\n\n* Group A\n\n  * Lymphadenopathy, increase ≥50%\n  * Hepatomegaly, increase ≥50%\n  * Splenomegaly, increase ≥50%\n  * Blood lymphocytes, increase ≥ 50% over baseline\n* Group B\n\n  * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL\n  * Hemoglobin, decrease of \\> 2 g/dL from baseline secondary to CLL","dispersionType":"95% Confidence Interval","groups":[{"description":"Ibrutinib 420 mg daily.","id":"OG000","title":"Ibrutinib"},{"description":"Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.","id":"OG001","title":"Chlorambucil"}],"paramType":"MEDIAN","populationDescription":"Intention to treat","reportingStatus":"POSTED","timeFrame":"Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.","title":"PFS (Progression Free Survival)","type":"PRIMARY","unitOfMeasure":"Months"}