{"analyses":[{"groupDescription":"To preserve the study wise type I error rate of 0.05, the primary and secondary endpoints were tested based on serial gatekeeping testing procedure at the two-sided significance level of 0.05 according to the hierarchical order of the primary analysis outcome measures presented in this record.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0045","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.2"},{"groupId":"OG001","value":"13.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"description":"Percentage of participants with platelet counts increase ≥ 50% over baseline continuously for ≥ 56 days without blood transfusion or growth factors.","groups":[{"description":"Ibrutinib (IBR) given orally at a dose of 420 mg/day until progressive disease or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until progressive disease or unacceptable toxicity.","id":"OG000","title":"IBR+OB"},{"description":"Chlorambucil (CLB) given orally at a dose of 0.5 mg/kg body weight up to a total of 6 cycles on Days 1 and 15 of each cycle or until disease progression or unacceptable toxicity.\n\nIntravenous obinutuzumab (OB) given on Days 1 and 2 (100 mg on Day 1 and 900 mg on Day 2), 1000 mg on Days 8 and 15 of Cycle 1 and 1000 mg on Day 1 of each cycle up to 6 cycles or until disease progression or unacceptable toxicity.","id":"OG001","title":"CLB+OB"}],"paramType":"NUMBER","populationDescription":"Intent to Treat population: all randomized participants","reportingStatus":"POSTED","timeFrame":"Median follow-up time was 31.3 months at the time of the primary analysis (data cutoff date: 26 March 2018).","title":"Primary Analysis: Rate of Sustained Platelet Improvement","type":"SECONDARY","unitOfMeasure":"percentage of participants"}