{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"35"}]}],"title":"AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"}]}],"title":"SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.","groups":[{"description":"In CE Phase, Participants with RRMM received 0.95 mg/ kg belantamab mafodotin 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 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":"CE Phase: 0.95mg/kg Belantamab Mafodotin Q3W + Nirogacestat"},{"description":"In CE Phase, Participants with RRMM received 2.5 mg/ kg belantamab mafodotin IV infusion as powder for solution Q3W, infused over 30- 60 minutes on day 1 of 21-day cycles until disease progression, intolerable toxicity, informed consent withdrawal, the end of the sub-study or death.","id":"OG001","title":"CE Phase: 2.5mg/kg Belantamab Mafodotin Q3W"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population","reportingStatus":"POSTED","timeFrame":"Up to approximately 253 weeks","title":"CE Phase: Number of Participants With AEs and SAEs","type":"SECONDARY","unitOfMeasure":"Participants"}