{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"48.0","upperLimit":"97.1","value":"68.3"},{"groupId":"OG001","lowerLimit":"57.4","upperLimit":"90.6","value":"72.1"}]}],"title":"Cmax, Course 1 Dose 1, n=14,19"},{"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":"386","upperLimit":"561","value":"465"}]}],"title":"Cmax, Course 1 Dose 3, n=0,19"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"195","upperLimit":"344","value":"259"},{"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":"Cmax, 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":"523","upperLimit":"783","value":"640"}]}],"title":"Cmax, Course 1 Dose 5, n=0,18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.3","upperLimit":"27.4","value":"3.0"},{"groupId":"OG001","lowerLimit":"2.0","upperLimit":"32.2","value":"8.0"}]}],"title":"Ctrough, Course 1 Dose 2, n=7,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"91.3","value":"13.9"},{"groupId":"OG001","lowerLimit":"67.3","upperLimit":"217","value":"121"}]}],"title":"Ctrough, Course 1 Dose 3, n=11,19"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.3","upperLimit":"128","value":"23.4"},{"groupId":"OG001","lowerLimit":"95.3","upperLimit":"344","value":"181"}]}],"title":"Ctrough, Course 1 Dose 4, n=13,21"},{"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":"127","upperLimit":"489","value":"249"}]}],"title":"Ctrough, Course 1 Dose 5, n=0,18"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"33.1","upperLimit":"85.6","value":"53.2"},{"groupId":"OG001","lowerLimit":"42.8","upperLimit":"98.2","value":"64.8"}]}],"title":"Cmax, Course 2 Dose 1, n=9,11"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"420","upperLimit":"730","value":"554"},{"groupId":"OG001","lowerLimit":"436","upperLimit":"762","value":"577"}]}],"title":"Cmax, Course 2 Dose 3, n=8,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"339","upperLimit":"825","value":"528"},{"groupId":"OG001","lowerLimit":"616","upperLimit":"1046","value":"803"}]}],"title":"Cmax, Course 2 Dose 5, n=10,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"52.7","value":"8.1"},{"groupId":"OG001","lowerLimit":"4.7","upperLimit":"89.2","value":"20.4"}]}],"title":"Ctrough, Course 2 Dose 2, n=7,10"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"64.6","upperLimit":"319","value":"144"},{"groupId":"OG001","lowerLimit":"102","upperLimit":"280","value":"169"}]}],"title":"Ctrough, Course 2 Dose 3, n=8,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"110","upperLimit":"458","value":"225"},{"groupId":"OG001","lowerLimit":"200","upperLimit":"482","value":"310"}]}],"title":"Ctrough, Course 2 Dose 4, n=11,12"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"155","upperLimit":"503","value":"279"},{"groupId":"OG001","lowerLimit":"273","upperLimit":"542","value":"384"}]}],"title":"Ctrough, Course 2 Dose 5, n=11,12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"description":"Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. 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 determined.","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":"Cmax and Ctrough of Ofatumumab","type":"SECONDARY","unitOfMeasure":"micrograms/milliliter (µg/ml)"}