{"analyses":[{"groupDescription":"IRR Preferred Term\n\nTo 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":"0.0835","statisticalMethod":"Fisher Exact"},{"groupDescription":"IRR By Customized SMQ\n\nTo 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":"0.1944","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.7"},{"groupId":"OG001","value":"8.6"}]}],"title":"IRR (Preferred Term)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.4"},{"groupId":"OG001","value":"9.5"}]}],"title":"By Customized SMQ"}],"denoms":[{"counts":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"116"}],"units":"Participants"}],"description":"Percentage of participants experiencing grade ≥ 3 (severe or life threatening) or serious IRR adverse events that started on the day of an obinutuzumab infusion and were assessed as related or possibly related to obinutuzumab. Categories included those events with the Medical Dictionary for Regulatory Activities (MedDRA) dictionary preferred term of IRR and those events which are among the customized standardized MedDRA query (SMQ) for IRR.","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 Grade ≥ 3 or Serious Infusion-Related Reaction (IRR) Adverse Events","type":"SECONDARY","unitOfMeasure":"percentage of participants"}