{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}],"title":"TEAE Grade >= 3"}],"title":"Participants with any TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}],"title":"TEAE Grade >= 3"}],"title":"Participants with any TEAEs related to TC-510"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}],"title":"TEAE Grade >= 3"}],"title":"Participants with any TEAEs Grade >=3 related to TC-510"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}],"title":"TEAE Grade >= 3"}],"title":"Participants with any Serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}],"title":"TEAE Grade >= 3"}],"title":"Participants with Serious TEAEs related to TC-510"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}],"title":"TEAE Grade >= 3"}],"title":"Subjects with any Serious TEAEs >=Grade 3 related to TC-510"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}],"title":"TEAE Grade >= 3"}],"title":"Participants with any Serious TEAEs with fatal outcome"}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510.\n\nTo be defined as serious, the event met at least one of the following serious criteria:\n\n* Fatal\n* Life-threatening (places the patient at immediate risk of death)\n* Requires in-patient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Congenital anomaly/birth defect\n* Other medically important serious event","groups":[{"description":"Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.","id":"OG000","title":"Phase 1"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The modified ITT Population included all participants enrolled and treated with TC-510.","reportingStatus":"POSTED","timeFrame":"From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)","title":"Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs","type":"PRIMARY","unitOfMeasure":"Participants"}