{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Dose limiting toxicity (DLT) is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.","groups":[{"description":"Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv)\n\nArm 1 Moxetumomab Pasudotox-tdfk + Rituximab\n\nDose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle.\n\nRituximab will be administered at 375mg/m\\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.","id":"OG000","title":"Moxetumomab - Dose Escalation 30 mcg/kg"},{"description":"Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience\n\nArm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience\n\nMoxetumomab pasudotox-tdfk is administered at 40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle.\n\nRuxience will be administered at 375mg/m\\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)","id":"OG001","title":"Moxetumomab - Dose Expansion 40 mcg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose","title":"Number of Participants With a Dose-limiting Toxicity (DLT)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}