{"analyses":[{"ciLowerLimit":"1.269","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.852","estimateComment":"Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Adjusted geometric mean ratio","paramValue":"1.533"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"89.54","value":"61.50"},{"groupId":"OG001","spread":"55.27","value":"97.53"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.","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 pharmacokinetic (PK) data available were included in the analysis.","reportingStatus":"POSTED","timeFrame":"+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration","title":"Part 2: Rituximab C Trough Levels at Cycle 5","type":"PRIMARY","unitOfMeasure":"μg/mL"}