{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"Dose limiting toxicity was defined as:\n\nAny new non-hematological AE of Grade 3 or higher toxicity using the NCI CTCAE (Version 4.03), which is probably or definitely related to AUTO2 therapy, which occurs within the DLT evaluation period, and which fails to resolve to Grade 2 or better within 14 days, despite appropriate supportive measures; A Grade 4 CRS; Any other reason for activation of the safety switch after receiving AUTO2; Any other fatal event (Grade 5) or life-threatening event (Grade 4) that cannot be managed with conventional supportive measures or which in the opinion of the SEC necessitates dose reduction or other modification to trial treatment to avoid a similar hazard in future patients. Effort should be made to perform an autopsy in case of fatal event where the aetiology is unclear; Any event that in the opinion of treating investigators and/or Medical Monitor puts the patient at undue risk may also be considered a DLT.","groups":[{"description":"Relapsed or refractory myeloma patients.","id":"OG000","title":"AUTO2"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 28 days post-infusion","title":"Phase I - Number of Subjects With a Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}