{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"SAEs occurring between leukapheresis and lymphodepleting chemotherapy (LDC)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"SAEs occurring between LDC and JCAR017 infusion"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"SAEs occurring between JCAR017 infusion and Day 30"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"SAEs occurring between Day 31 and Day 90"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"SAEs occurring between Day 91 and end of study"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"}],"units":"Participants"}],"description":"A serious adverse event (SAE) is defined as any adverse event (AE) occurring at any dose that:\n\n* Results in death;\n* Is life-threatening (ie, in the opinion of the Investigator, the participant is at immediate risk of death from the AE);\n* Requires inpatient hospitalization or prolongation of existing hospitalization (hospitalization is defined as an inpatient admission, regardless of length of stay).\n* Results in persistent or significant disability/incapacity (a substantial disruption of the participant's ability to conduct normal life functions);\n* Is a congenital anomaly/birth defect;\n* Constitutes an important medical event. Graded according to NCI CTCAE (Version 4.03) guidelines where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life threatening, grade 5 = death.","groups":[{"description":"JCAR017 was infused at a dose of 100 x 10\\^6 JCAR017-positive transfected viable T cells (50 × 10\\^6 CD8+ CAR+ T cells and 50 × 10\\^6 CD4+ CAR+ T cells), on Day 1 (2 to 7 days after completion of Lymphodepleting chemotherapy).","id":"OG000","title":"Cohort 7: Meeting Cohort 1 Criteria Suitable for Treatment in an Outpatient Setting"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants in the JCAR017 treated set. Prespecified to be reported for cohort 7 only","reportingStatus":"POSTED","timeFrame":"From leukapheresis to end of study (up to approximately 63 months)","title":"Number of Participants With Serious Adverse Events (SAEs) in Cohort 7","type":"PRIMARY","unitOfMeasure":"Participants"}