{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.99","upperLimit":"25.07","value":"4.27"},{"comment":"The intended reverse Kaplan-Meier model could not be built with so few patients in the group.","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The intended reverse Kaplan-Meier model could not be built with so few patients in the group.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The intended reverse Kaplan-Meier model could not be built with so few patients in the group.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The intended reverse Kaplan-Meier model could not be built with so few patients in the group.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"The intended reverse Kaplan-Meier model could not be built with so few patients in the group.","groupId":"OG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"}],"units":"Participants"}],"description":"DOR was defined as the time from the first observed CR or partial response (PR) to documented disease progression or death due to any cause, for patients who were considered as responders.\n\nPatients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis.\n\nPatients who proceeded to stem cell transplantation (SCT) after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT).\n\nPatients who received new non-protocol anticancer therapies other than SCT were censored at the date of last adequate assessment prior to the new therapy.\n\nPatients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event.\n\nData for DOR were pooled for analysis because the number of patients was \\<5 for all of the groups and the intended model cannot be built with such a small sample size.","dispersionType":"95% Confidence Interval","groups":[{"description":"All patients who received an infusion of AUTO4 who were classified as responders and who were not censored.","id":"OG000","title":"All Treated Patients Evaluable for DOR"},{"description":"Patients received 25x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG001","title":"Phase I Dose Escalation - Cohort 1"},{"description":"Patients received 75x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG002","title":"Phase I Dose Escalation - Cohort 2"},{"description":"Patients received 225x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG003","title":"Phase I Dose Escalation - Cohort 3"},{"description":"Patients received 450x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG004","title":"Phase I Dose Escalation - Cohort 4"},{"description":"Patients received 225x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG005","title":"Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3"},{"description":"Patients received 450x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG006","title":"Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4"},{"description":"Patients received 900x10\\^6 RQR8/aTRBC1 CAR T-positive cells","id":"OG007","title":"Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5"}],"paramType":"MEDIAN","populationDescription":"Patients who were considered as responders and were not censored were included in the analysis.\n\nData for DOR were pooled for analysis because the number of patients was \\<5 for all of the groups and the intended reverse Kaplan-Meier model cannot be built with such a small sample size.\n\nThe intended reverse Kaplan-Meier model could not be built for 1 patient.","reportingStatus":"POSTED","timeFrame":"Up to 24 months","title":"Evaluate Duration of Response (DOR) Following Treatment With AUTO4.","type":"SECONDARY","unitOfMeasure":"months"}