{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Possibly related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Probably related"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Definitely related"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"4"}],"units":"Participants"}],"description":"A DLT is defined as any grade 3 or 4 toxicity possibly, probably or definitely related to the rhIL-15 treatment that occurs during the first 6 weeks of treatment with some exceptions such as grade 3 or 4 lymphopenia, and grade 3 neutropenia for example.","groups":[{"description":"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks per dosing schema to determine the maximum tolerated dose (MTD)\n\nIL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.\n\nalemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.","id":"OG000","title":"Level 1 - 0.5 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab"},{"description":"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks\n\nIL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.\n\nalemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.","id":"OG001","title":"Level 2 - 1 mcg/kg/Dose of Interleukin-15 (IL-15) Followed by Alemtuzumab"},{"description":"IL-15 for 10 doses over two weeks followed by alemtuzumab for 4 weeks\n\nIL-15 plus: Recombinant Human IL-15 (subcutaneous (s.c.) rhIL-15) by s.c. injection Monday-Friday over two weeks.\n\nalemtuzumab: Alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.","id":"OG002","title":"Level 3 - 2 mcg/kg/Dose of Interleukin 15 (IL-15) Followed by Alemtuzumab"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"6 weeks","title":"Number of Dose-limiting Toxicities (DLTs) of Subcutaneous Recombinant Human IL-15 (s.c. rhIL-15) Administered With 3 Times Per Week Intravenous (IV) Alemtuzumab","type":"PRIMARY","unitOfMeasure":"toxicities"}