{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11637","upperLimit":"39424","value":"21419"},{"comment":"No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"AUC(0-tau), Course 1 Dose 4, n=13,0"},{"categories":[{"measurements":[{"comment":"No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"56462","upperLimit":"101028","value":"75526"}]}],"title":"AUC(0-tau), Course 1 Dose 5, n=0,18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53956","upperLimit":"270842","value":"120886"},{"comment":"No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"AUC(0-inf), Course 1 Dose 4, n=9,0"},{"categories":[{"measurements":[{"comment":"No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"220019","upperLimit":"698454","value":"392012"}]}],"title":"AUC(0-inf), Course 1 Dose 5, n=0,18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36684","upperLimit":"102296","value":"61259"},{"groupId":"OG001","lowerLimit":"82044","upperLimit":"137663","value":"106275"}]}],"title":"AUC(0-tau), Course 2 Dose 5, n=10,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70622","upperLimit":"695814","value":"221675"},{"groupId":"OG001","lowerLimit":"286020","upperLimit":"901528","value":"507794"}]}],"title":"AUC(0-inf), Course 2 Dose 5, n=8,12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"description":"AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \\[Weeks (Wk.) 1 through 4\\]) (300 milligrams \\[mg\\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.","id":"OG000","title":"300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5"},{"description":"Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \\[Weeks 1 through 5\\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.","id":"OG001","title":"300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be calculated..","reportingStatus":"POSTED","timeFrame":"From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7","title":"AUC(0-tau) and AUC(0-inf) of Ofatumumab","type":"SECONDARY","unitOfMeasure":"micrograms X hours/milliliters (µg.h/mL)"}