{"analyses":[{"ciLowerLimit":"34.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"55.5","groupDescription":"Includes subjects with best overall response: CR, CRi, PR or nPR.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","paramType":"Difference in Response Rates","paramValue":"45.1","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"21.0","upperLimit":"32.6","value":"26.5"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"3.1","value":"0.0"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.9","upperLimit":"5.4","value":"2.5"},{"groupId":"OG001","lowerLimit":"0.2","upperLimit":"6","value":"1.7"}]}],"title":"Complete Response incomplete (CRi)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"40.6","upperLimit":"53.6","value":"47.1"},{"groupId":"OG001","lowerLimit":"23.1","upperLimit":"40.5","value":"31.4"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.7","upperLimit":"4.8","value":"2.1"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"3.1","value":"0"}]}],"title":"Nodular Partial Response (nPR)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2","upperLimit":"7.6","value":"4.2"},{"groupId":"OG001","lowerLimit":"14.2","upperLimit":"29.7","value":"21.2"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.0","upperLimit":"7.6","value":"4.2"},{"groupId":"OG001","lowerLimit":"20.8","upperLimit":"37.9","value":"28.8"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"comment":"95% CI was not estimated.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"13.4"},{"comment":"95% CI was not estimated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"16.9"}]}],"title":"No Response Assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"238"},{"groupId":"OG001","value":"118"}],"units":"Participants"}],"description":"Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10\\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \\>1.5 x 10\\^9/L, Platelets \\>100 x 10\\^9/L, Hemoglobin \\>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \\>1.5 x 10\\^9/ or ≥50% increase, Platelets \\>100 x 10\\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \\[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).","id":"OG000","title":"Obinutuzumab + Chlorambucil (GClb)"},{"description":"Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.","id":"OG001","title":"Chlorambucil (Clb)"}],"paramType":"NUMBER","populationDescription":"Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.","reportingStatus":"POSTED","timeFrame":"Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)","title":"Percentage of Participants With Best Overall Response","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}