{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"9"}],"units":"Participants"}],"description":"The Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only):\n\n* any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 6.2.1.1 for full definition)\n* any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration\n* grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle","groups":[{"description":"Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.","id":"OG000","title":"ALT-803, IV, 1 mcg/kg"},{"description":"Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.","id":"OG001","title":"ALT-803, IV, 3 mcg/kg"},{"description":"Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.","id":"OG002","title":"ALT-803, IV, 6 mcg/kg"},{"description":"Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.","id":"OG003","title":"ALT-803, IV, 10 mcg/kg"},{"description":"Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.","id":"OG004","title":"ALT-803, SQ, 6 mcg/kg"},{"description":"Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.","id":"OG005","title":"ALT-803, SQ, 10 mcg/kg"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Number of Participants With Dose Limiting Toxicity (DLT) Events","type":"PRIMARY","unitOfMeasure":"Participants"}