{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.302","value":"0.001"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"title":"Baseline: CTL019 Pool 1 CD3+ CD4+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.110","value":"0.00346"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Month 24: CTL019 Pool 1 CD3+ CD4+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.320","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"title":"Baseline: CTL019 Pool 2 CD3+ CD4+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.140","value":"0.00275"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Month 24: CTL019 Pool 2 CD3+ CD4+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"2.38","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"title":"Baseline: CTL019 Pool 1 CD3+ CD8+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.144","value":"0.001"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Month 24: CTL019 Pool 1 CD3+ CD8+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.350","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"title":"Baseline: CTL019 Pool 2 CD3+ CD8+ IFNg+"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0.520","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Month 24: CTL019 Pool 2 CD3+ CD8+ IFNg+"}],"denoms":[{"counts":[{"groupId":"OG000","value":"94"}],"units":"Participants"}],"description":"Activation of T-cells in peripheral blood mononuclear cells collected from participants in response to mCAR19-derived peptides was used to assess the cellular immunogenicity against tisagenlecleucel. T-cell activation was measured by the percentage of interferon gamma (IFNg+) cells by flow cytometry. Cellular responses to mCART peptides were measured pre-infusion (enrollment) and post-tisagenlecleucel infusion.\n\nPool 1 and Pool 2 are a pool of 60 peptides (peptides 1-60) and 59 peptides (peptides 61-119) , respectively, corresponding to the CTL019 transgene product. Together, they comprised 119 peptides spanning the CTL019 transgene product and were used to stimulate PBMCs to detect antigen-specific T cell responses via intracellular cytokine staining.","dispersionType":"Full Range","groups":[{"description":"All participants who were enrolled in the study","id":"OG000","title":"CTL019"}],"paramType":"MEDIAN","populationDescription":"Efficacy analysis set (EAS) comprised of all patients who received tisagenlecleucel, and had measurable disease at baseline per IRC. Non-measurable disease at baseline is defined as absence of index lesion at baseline disease evaluation (i.e. no disease at baseline).","reportingStatus":"POSTED","timeFrame":"pre-infusion (pre-Lymph depletion evaluation), 24 months post-infusion","title":"Cellular Immunogenicity: Percentage of Interferon Gamma (IFNg+) Cells by Flow Cytometry Per IRC Assessment","type":"SECONDARY","unitOfMeasure":"% of interferon gamma (IFNg+) cells"}