{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1600"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"56"}],"units":"Participants"}],"description":"Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m\\^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.","groups":[{"description":"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\\^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 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":"OG000","title":"Part 1: Rituximab SC"}],"paramType":"NUMBER","populationDescription":"Enrolled (non-randomized) Pharmacokinetic Evaluable Population (Part 1) included all participants from Part 1 who did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or have unavailable or incomplete data which could influence the pharmacokinetic analysis.","reportingStatus":"POSTED","timeFrame":"Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose","title":"Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab","type":"PRIMARY","unitOfMeasure":"mg"}