{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"title":"Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"title":"Drug-related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"}]}],"title":"Drug-related Grade 3 or higher TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"TEAE leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Treatment-emergent SAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.","groups":[{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \\<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.","id":"OG000","title":"Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)"},{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \\<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.","id":"OG001","title":"Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)"},{"description":"Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.","id":"OG002","title":"Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)"}],"paramType":"NUMBER","populationDescription":"Participants who received a TCR-T cell infusion (Safety Analysis Set).","reportingStatus":"POSTED","timeFrame":"From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.","title":"Number of Participants With Treatment-Emergent Adverse Events","type":"PRIMARY","unitOfMeasure":"participants"}