{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"description":"A DLT is non-relapse mortality before day 30 post transplantation regardless of attribution to palifermin. Persons who expire from malignancy related causes are not considered DLTs; and non-hematologic Common Terminology Criteria for Adverse Events (CTCAE) ≥ grade 4 adverse events (AEs), occurring within 14 days after administration of palifermin that are determined by the investigator to be at least possibly related to the study drug. An isolated laboratory value is not considered an AE unless it meets the guidelines. Note: Participants will not be removed from study therapy due to palifermin toxicity as only 1 dose is administered. DLT criteria are established only to determine dose levels for subsequent participants.","groups":[{"description":"Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG000","title":"1/Phase 1: Dose Escalation Arm - Palifermin"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"15/16 participants were analyzed because 1 participant was a screen failure post induction for research phase.","reportingStatus":"POSTED","timeFrame":"≤day 30 post-transplant","title":"Phase 1: Number of Participants With a Dose-limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}