{"analyses":[{"ciLowerLimit":"1.24","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.53","groupDescription":"The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Geometric mean ratio","paramValue":"1.38"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"32.51","value":"2734.21"},{"groupId":"OG001","spread":"37.59","value":"3778.93"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \\[up to 26 months\\])","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 PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)","title":"Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab","type":"SECONDARY","unitOfMeasure":"mcg*day/mL"}