{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"DLT was defined as axicabtagene ciloleucel-related events with onset within first 30 days following infusion:\n\n* Grade (GR) 4 neutropenia lasting \\> 21 days and GR 4 thrombocytopenia lasting \\> 35 days from day of cell transfer;\n* Any axicabtagene ciloleucel-related AE requiring intubation;\n* All other GR 3 toxicities lasting \\> 3 days and all GR 4 toxicities, with exception of following conditions which were not considered DLTs: aphasia/dysphasia or confusion/cognitive disturbance which resolved to GR ≤ 1 within 2 weeks and to baseline within 4 weeks; fever GR 3; myelosuppression defined as lymphopenia, decreased hemoglobin, neutropenia and thrombocytopenia unless neutropenia and thrombocytopenia met DLT definition described above; immediate hypersensitivity reactions occurring within 2 hours of cell infusion that were reversible to a ≤ GR 2 within 24 hours of cell administration with standard therapy; hypogammaglobulinemia GR 3 or 4.","groups":[{"description":"Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\\^2 intravenously \\[IV\\] over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.","id":"OG000","title":"Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT-Evaluable Analysis Set included participants treated in Phase 1 dosing cohort who received the target dose and were followed for at least 30 days after the axicabtagene ciloleucel infusion; or dose of anti-CD19 CAR T cells (axicabtagene ciloleucel) lower than the target for that cohort and experienced a DLT during the 30 day post-infusion period.","reportingStatus":"POSTED","timeFrame":"First infusion date of axicabtagene ciloleucel up to 30 days","title":"Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}