{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"5"}],"units":"Participants"}],"description":"DLTs were defined as: All Grade 5 toxicities, Grade 4 thrombocytopenia, neutropenia or anemia and Grade 3/4 febrile neutropenia and hemorrhage associated with thrombocytopenia, all non-hematological toxicities of grade ≥3 (with exceptions per protocol), Grade 4 tumor lysis syndrome (TLS), Grade 4 infusion-related reaction (IRR), and any liver toxicity of elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times or greater above the upper limit of normal (ULN) with serum total bilirubin of ≥2 times the upper limit of normal, without findings of cholestasis and in the absence of alternative etiologies. DLTs were graded for severity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.","groups":[{"description":"Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by IV infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).","id":"OG000","title":"RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg"},{"description":"Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.","id":"OG001","title":"RRMM Dose Escalation: GEN3014 2 mg/kg"},{"description":"Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.","id":"OG002","title":"RRMM Dose Escalation: GEN3014 4 mg/kg"},{"description":"Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.","id":"OG003","title":"RRMM Dose Escalation: GEN3014 8 mg/kg"},{"description":"Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.","id":"OG004","title":"RRMM Dose Escalation: GEN3014 16 mg/kg"},{"description":"Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.","id":"OG005","title":"RRMM Dose Escalation: GEN3014 24 mg/kg"},{"description":"Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.","id":"OG006","title":"R/R AML Dose Escalation: GEN3014 Dose Level 1"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Dose-Determining Analysis Set (DDS) included all FAS participants (all enrolled participants who received at least 1 dose of trial drug \\[GEN3014 or daratumumab SC\\]) in the Dose Escalation part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 28 days of dosing (ie, in Cycle 1).","reportingStatus":"POSTED","timeFrame":"28 days during the first cycle (cycle =28 days)","title":"Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}