{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.","groups":[{"description":"Participants were planned to receive modakafusp alfa at dose level 1 (DL1) \\[selected from Phase 1 Dose Escalation\\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.","id":"OG000","title":"Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab"},{"description":"Participants were planned to receive modakafusp alfa at dose level 2 (DL2) \\[selected from Phase 1 Dose Escalation\\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.","id":"OG001","title":"Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab"}],"populationDescription":"After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons (no safety concerns). Thus, no participants were enrolled for Phase 2a \\& no data was collected for this outcome measure due to study termination.","reportingStatus":"POSTED","timeFrame":"Phase 2a: Up to 15.9 months","title":"Phase 2a: Number of Participants Reporting One or More TEAEs and Per Severity","type":"SECONDARY"}