{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35"}]}],"title":"Worst Grade 1 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}],"title":"Worst Grade 2 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"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":"0"}]}],"title":"Worst Grade ≥ 3 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}],"title":"Worst Grade 1 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Worst Grade 2 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Worst Grade 3 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Worst Grade 4 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Worst Grade 5 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Worst Grade ≥ 3 Neurologic Toxicities"}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"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 HGBCL after 2 systemic lines of therapy may have received 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 on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). 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 6"}],"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: 4.1 years)","title":"Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","type":"PRIMARY","unitOfMeasure":"percentage of participants"}