{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"0"}]}]}],"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":"An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population included all participants who received at least 1 dose of any component of the combination therapy.","reportingStatus":"POSTED","timeFrame":"Up to approximately 253 weeks","title":"DE Phase: Number of Participants With Adverse Events (AEs)","type":"PRIMARY","unitOfMeasure":"Participants"}