{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"3"}],"units":"Participants"}],"description":"Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG000","title":"Phase I Palifermin Dose Level 1: 180 mcg/kg Intravenous (IV) on Day-7"},{"description":"Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG001","title":"Phase I Palifermin Dose Level 2: 360 mcg/kg Intravenous (IV) on Day-7"},{"description":"Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG002","title":"Phase I Palifermin Dose Level 3: 540 mcg/kg Intravenous (IV) on Day-7"},{"description":"Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG003","title":"Phase I Palifermin Dose Level 4: 720 mcg/kg Intravenous (IV) on Day-7"},{"description":"Induction chemotherapy, then palifermin at the recommended phase 2 dose (RP2D) determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.","id":"OG004","title":"Phase 2 Palifermin: 720 mcg/kg Intravenous (IV) Dose"},{"description":"Participants were enrolled but not treated on Research Phase (Palifermin + Transplant).","id":"OG005","title":"Participants Enrolled But Not Treated on Research Phase (Palifermin + Transplant)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"All adverse events, including clinically significant abnormal findings on laboratory evaluations, regardless of severity, will be followed until return to baseline or stabilization of event, up to 5 years.","title":"Phase I and/or Phase 2: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"Participants"}