{"denoms":[{"counts":[{"groupId":"BG000","value":"354"},{"groupId":"BG001","value":"175"},{"groupId":"BG002","value":"529"}],"units":"Participants"}],"groups":[{"description":"Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.","id":"BG000","title":"Arm A (Ibrutinib, Rituximab)"},{"description":"Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.","id":"BG001","title":"Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"7.5","value":"56.7"},{"groupId":"BG001","spread":"7.2","value":"56.7"},{"groupId":"BG002","spread":"7.4","value":"56.7"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"118"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"173"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"236"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"356"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"10"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"333"},{"groupId":"BG001","value":"167"},{"groupId":"BG002","value":"500"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"19"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"29"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"318"},{"groupId":"BG001","value":"160"},{"groupId":"BG002","value":"478"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"12"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}],"populationDescription":"All randomized patients were included in this analysis."}