{"analyses":[{"ciLowerLimit":"0.479","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.772","estimateComment":"The hazard ratio and its 95% confidence interval were estimated using a Cox regression model with treatment as the only covariate.","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":"0.8057","paramType":"Hazard Ratio (HR)","paramValue":"0.921","statisticalComment":"The treatment effect was tested with an unstratified log rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"77.4","upperLimit":"90.9","value":"85.5"},{"groupId":"OG001","lowerLimit":"76.8","upperLimit":"90.4","value":"84.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"description":"OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive.\n\nAs the median OS was not reached in either treatment arm at the time of the analysis, Kaplan Meier landmark estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 30 \\[primary analysis\\]) are presented.","dispersionType":"95% Confidence Interval","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":"Month 30 (Median follow-up time was 31.3 months at the time of the primary analysis [data cutoff date: 26 March 2018]).","title":"Primary Analysis: Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 30","type":"SECONDARY","unitOfMeasure":"percentage of participants"}