{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"720"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"MTD is defined as the dose level at which no more than 1 (of ≤ 6) participants who experience dose-limiting toxicity (DLT), and the dose below that at which at least 2 (of ≤ 6) participants have a DLT as a result of the drug. A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. and non-hematologic grade 4 (life-threatening) adverse events within 14 days after treatment with palifermin possibly related to drug.","groups":[{"description":"All participants who received at least one dose of palifermin.","id":"OG000","title":"All Phase I Participants"}],"paramType":"NUMBER","populationDescription":"All participants = (total # for phase 1).","reportingStatus":"POSTED","timeFrame":"Approximately 30-day post-transplant","title":"Phase I: Maximum Tolerated Dose (MTD) of Palifermin","type":"PRIMARY","unitOfMeasure":"mcg/kg"}