{"classes":[{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"0.0","value":"0.00"},{"groupId":"OG003","lowerLimit":"0.0","upperLimit":"579.0","value":"0.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"0.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY -2, PRE-DOSE"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"769.0","value":"377.00"},{"groupId":"OG003","lowerLimit":"0.8","upperLimit":"1270.0","value":"251.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"272.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY -2, 30 MINUTES"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"4.3","upperLimit":"804.0","value":"371.00"},{"groupId":"OG003","lowerLimit":"21.2","upperLimit":"968.0","value":"343.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"345.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY -2, 1 HOUR"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"19.3","upperLimit":"688.0","value":"307.00"},{"groupId":"OG003","lowerLimit":"124.0","upperLimit":"1360.0","value":"319.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"153.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY -2, 2 HOURS"},{"categories":[{"measurements":[{"groupId":"OG002","lowerLimit":"75.3","upperLimit":"278.0","value":"168.00"},{"groupId":"OG003","lowerLimit":"67.1","upperLimit":"611.0","value":"161.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"52.30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY -2, 4 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"0.0","value":"0.00"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"0.0","value":"0.00"},{"groupId":"OG002","lowerLimit":"34.7","upperLimit":"564.0","value":"98.55"},{"groupId":"OG003","lowerLimit":"41.3","upperLimit":"1000.0","value":"88.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, PRE-DOSE"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.9","upperLimit":"1560.0","value":"244.00"},{"groupId":"OG001","lowerLimit":"78.5","upperLimit":"914.0","value":"348.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"253.00"},{"groupId":"OG003","lowerLimit":"188.0","upperLimit":"998.0","value":"670.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"585.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, 30 MINUTES"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"122.0","upperLimit":"1680.0","value":"306.50"},{"groupId":"OG001","lowerLimit":"108.0","upperLimit":"923.0","value":"490.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"465.00"},{"groupId":"OG003","lowerLimit":"389.0","upperLimit":"1240.0","value":"651.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"547.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, 1 HOUR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"126.0","upperLimit":"1060.0","value":"265.50"},{"groupId":"OG001","lowerLimit":"252.0","upperLimit":"369.0","value":"325.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"726.00"},{"groupId":"OG003","lowerLimit":"217.0","upperLimit":"1100.0","value":"413.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"207.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, 2 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58.4","upperLimit":"431.0","value":"110.00"},{"groupId":"OG001","lowerLimit":"50.6","upperLimit":"149.0","value":"127.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"366.00"},{"groupId":"OG003","lowerLimit":"103.0","upperLimit":"625.0","value":"215.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"113.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, 4 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.7","upperLimit":"254.0","value":"50.90"},{"groupId":"OG001","lowerLimit":"30.4","upperLimit":"102.0","value":"74.80"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"CYCLE 1 DAY 1, 8 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"93.5","upperLimit":"409.0","value":"176.00"},{"groupId":"OG001","lowerLimit":"72.3","upperLimit":"309.0","value":"161.00"},{"groupId":"OG002","lowerLimit":"42.9","upperLimit":"339.0","value":"152.00"},{"groupId":"OG003","lowerLimit":"80.0","upperLimit":"1390.0","value":"171.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"138.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 4, PRE-DOSE"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"60.5","upperLimit":"490.0","value":"129.00"},{"groupId":"OG001","lowerLimit":"20.6","upperLimit":"1070.0","value":"379.50"},{"groupId":"OG002","lowerLimit":"53.9","upperLimit":"403.0","value":"174.50"},{"groupId":"OG003","lowerLimit":"144.0","upperLimit":"1140.0","value":"218.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"117.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 1 DAY 8, PRE-DOSE"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.3","upperLimit":"761.0","value":"86.60"},{"groupId":"OG001","lowerLimit":"2.1","upperLimit":"195.0","value":"63.73"},{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"149.0","value":"1.83"},{"groupId":"OG003","lowerLimit":"0.0","upperLimit":"724.0","value":"54.30"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"24.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, PRE-DOSE"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.3","upperLimit":"1830.0","value":"228.00"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"789.0","value":"12.70"},{"groupId":"OG002","lowerLimit":"1.2","upperLimit":"550.0","value":"122.00"},{"groupId":"OG003","lowerLimit":"58.7","upperLimit":"1190.0","value":"484.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"74.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, 30 MINUTES"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"78.6","upperLimit":"2260.0","value":"253.00"},{"groupId":"OG001","lowerLimit":"33.9","upperLimit":"773.0","value":"186.50"},{"groupId":"OG002","lowerLimit":"13.6","upperLimit":"726.0","value":"220.00"},{"groupId":"OG003","lowerLimit":"81.8","upperLimit":"1330.0","value":"422.00"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"171.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, 1 HOUR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"102.0","upperLimit":"1400.0","value":"236.50"},{"groupId":"OG001","lowerLimit":"54.9","upperLimit":"704.0","value":"162.00"},{"groupId":"OG002","lowerLimit":"81.9","upperLimit":"523.0","value":"274.00"},{"groupId":"OG003","lowerLimit":"119.0","upperLimit":"472.0","value":"334.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"124.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, 2 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"64.5","upperLimit":"941.0","value":"170.00"},{"groupId":"OG001","lowerLimit":"173.0","upperLimit":"400.0","value":"357.00"},{"groupId":"OG002","lowerLimit":"48.0","upperLimit":"426.0","value":"196.00"},{"groupId":"OG003","lowerLimit":"109.0","upperLimit":"326.0","value":"179.50"},{"comment":"Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual concentration for this single participant.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"58.20"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, 4 HOURS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.8","upperLimit":"823.0","value":"109.50"},{"groupId":"OG001","lowerLimit":"58.6","upperLimit":"203.0","value":"183.00"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"CYCLE 2 DAY 1, 8 HOURS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.","dispersionType":"Full Range","groups":[{"description":"In DE Phase, participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.95 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered twice a day (BID) on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG000","title":"DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat"},{"description":"In DE Phase, participants with RRMM received 1.9 mg/ kg belantamab mafodotin IV infusion as powder for solution once Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat administered BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG001","title":"DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat"},{"description":"In DE Phase, participants with RRMM received 1.0 mg/ kg belantamab mafodotin IV infusion as powder for solution once every 4 weeks (Q4W) for Cycle 1-2 and then once every 8 weeks (Q8W) from Cycle 2 onwards, infused over 30- 60 minutes on day 1 of 28-day cycles in Q4W and 56-day cycle in Q8W in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG002","title":"DE Phase: 1.0 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID"},{"description":"In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W for Cycle 1 and then Q8W from Cycle2 onwards, infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG003","title":"DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W/Q8W + Nirogacestat BID"},{"description":"In DE Phase, participants with RRMM received 1.4 mg/ kg belantamab mafodotin IV infusion as powder for solution Q4W, infused over 30- 60 minutes on day 1 of 28-day cycles in combination with 100 mg nirogacestat BID on day 1, 4, 8 and 15 of 21-day cycles. Treatment was administered until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG004","title":"DE Phase: 1.4 mg/kg Belantamab Mafodotin Q4W + Nirogacestat BID"}],"paramType":"MEDIAN","populationDescription":"Pharmacokinetic population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The \"0\" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.","reportingStatus":"POSTED","timeFrame":"PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, and 4H on Cycle (C) 1 Day (D) -2; PRE-DOSE (PD), Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C1D1; PD on C1D4 and D8 ; PD, Post-dose 30 Minutes, 1H, 2H, 4H, 8H on C2D1","title":"DE Phase: Plasma Concentration of Nirogacestat When Administered in Combination With Belantamab Mafodotin","type":"SECONDARY","unitOfMeasure":"ng/mL"}