{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"}]}],"title":"Worst Grade 1 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"46"}]}],"title":"Worst Grade 2 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 3 CRS"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"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":"26"}]}],"title":"Worst Grade 1 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"}]}],"title":"Worst Grade 2 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"}]}],"title":"Worst Grade 3 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Worst Grade 4 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Worst Grade 5 Neurologic Toxicities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Worst Grade ≥ 3 Neurologic Toxicities"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"}],"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 received debulking therapy (R-CHOP:rituximab 375mg/m\\^2 D1,doxorubicin 50mg/m\\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\\^2 D1,vincristine 1.4 mg/m\\^2 D1 or R-ICE:rituximab 375mg/ m\\^2 D1,ifosfamide 5g/m\\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\\^2 D1,gemcitabine 1000mg/m\\^2 D2,oxaliplatin 100mg/m\\^2 D2 or R-GDP:rituximab 375mg/m\\^2 D1 or D8,gemcitabine 1g/m\\^2 D1 \\& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), 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 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 BID starting on D0).D=Day.","id":"OG000","title":"Phase 2 (Safety Management Study): Cohort 5"}],"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: 4.4 years)","title":"Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades","type":"PRIMARY","unitOfMeasure":"percentage of participants"}