{"analyses":[{"ciLowerLimit":"1.36","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.94","estimateComment":"Geometric mean ratio adjusted for tumor load at baseline.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","paramType":"Geometric mean ratio","paramValue":"1.62"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"36.7","value":"83.1"},{"groupId":"OG001","spread":"43.2","value":"134.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Eight cycles of rituximab IV infusion (375 mg/m\\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\\^2) once every 8 weeks for 24 months.","id":"OG000","title":"Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)"},{"description":"First cycle of rituximab IV (375 mg/m\\^2) + 7 cycles of rituximab subcutaneously (SC) (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.","id":"OG001","title":"Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"Stage I pharmacokinetic (PK) evaluable population comprised all participants with data for Ctrough available at Cycle 7 and/or observed area under the serum concentration-time curve (AUC) available at Cycle 7. Participants were analyzed as per treatment received. Number of participants analyzed = participants analyzed for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Stage I: Cycle (Cy) 7 Day (D) 21 (within 2 hours predose on Cy8) of induction treatment (1 Cy=3 weeks)","title":"Stage I: Trough Serum Concentrations (Ctrough) of IV and SC Rituximab","type":"PRIMARY","unitOfMeasure":"micrograms per milliliter (mcg/mL)"}