{"analyses":[{"ciLowerLimit":"0.979","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.242","estimateComment":"Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Adjusted geometric mean ratio","paramValue":"1.102"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"38.61","value":"3630.43"},{"groupId":"OG001","spread":"37.52","value":"4088.78"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"51"}],"units":"Participants"}],"description":"AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"OG000","title":"Part 2 : Rituximab IV 500 mg/m^2"},{"description":"Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\\^2 on Days 1-3 (or as an oral dose of 24 mg/m\\^2 on Days 1-5 or 30-40 mg/m\\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\\^2 on Days 1-3 (or as an oral dose of 150 mg/m\\^2 on Days 1-5 or 200-250 mg/m\\^2 on Days 1-3).","id":"OG001","title":"Part 2: Rituximab SC 1600 mg"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Only participants who entered Part 2 of the study and had PK data available were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6","title":"Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6","type":"SECONDARY","unitOfMeasure":"μg*day/mL"}