{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}],"title":"Worst Grade 1 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59"}]}],"title":"Worst Grade 2 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Worst Grade 3 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 4 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 5 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Worst Grade ≥ 3 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"}]}],"title":"Worst Grade 1 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Worst Grade 2 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Worst Grade 3 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 4 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 5 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}],"title":"Worst Grade ≥ 3 Neurologic Toxicities"}],"denoms":[{"counts":[{"groupId":"OG000","value":"41"}],"units":"Participants"}],"description":"TEAE was defined as any AE with onset on or after the start of treatment. CRS events were graded by Lee et al 2014. Grade 1 : No life threatening symptoms and require symptomatic treatment only; Grade 2: Symptoms require and respond to moderate intervention; Grade 3: Symptoms require and respond to aggressive intervention; Grade 4: Life-threatening symptoms and requirements for ventilator support or CVVHD, and Grade 5: Death. Neurologic toxicities were graded by CTCAE version 4.03. Grade 1: Mild, asymptomatic or mild symptoms and intervention not indicated; Grade 2: Moderate and minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening and urgent intervention indicated; Grade 5: Death related to AE.","groups":[{"description":"Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\\^2 weekly for 3 weeks or bendamustine 90 mg/m\\^2 on Days 1 and 2 and rituximab 375mg/m\\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).","id":"OG000","title":"Phase 2 (Safety Management Study): Cohort 4"}],"paramType":"NUMBER","populationDescription":"The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel.","reportingStatus":"POSTED","timeFrame":"First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)","title":"Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","type":"PRIMARY","unitOfMeasure":"percentage of participants"}