{"analyses":[{"groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82.4"},{"groupId":"OG001","value":"35.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"136"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.","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":"NUMBER","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":"ORR (Overall Response Rate)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}