{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"10"},{"groupId":"OG004","value":"11"},{"groupId":"OG005","value":"5"}],"units":"Participants"}],"description":"DLTs were defined as adverse events that were at least possibly related to panobinostat that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 4 thrombocytopenia, grade 3 thrombocytopenia with bleeding, grade 3 thrombocytopenia that occurs twice within a treatment course, myelosuppression that causes greater than a 14-day delay between treatment courses, grade 4 neutropenia, grade 3 or 4 febrile neutropenia. Non-hematologic DLTs included any grade 3 or greater non-hematologic toxicities with a few exclusions (such as grade 3 nausea/vomiting that is responsive to antiemetics and that resolves to grade 2 or lower within 5 days, etc.), any grade 2 non-hematological toxicity that persists for more than 7 days and is considered sufficiently medically significant or sufficiently intolerable by patients, and any panobinostat-related non-hematological toxicity that results in a delay of treatment \\> 14 days between treatment courses.","groups":[{"description":"Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 10 mg/m\\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Stratum 1, Dose Level 1 (10 mg/m^2)"},{"description":"Recurrent or progressive DIPG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\\^2/day for three weeks on, one week off (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Stratum 1, Dose Level 2 (16 mg/m^2)"},{"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 16 mg/m\\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Stratum 2, Dose Level 1 (16 mg/m^2)"},{"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 22 mg/m\\^2/day for every other week (1 course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Stratum 2, Dose Level 2 (22 mg/m^2)"},{"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 28 mg/m\\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG004","title":"Stratum 2, Dose Level 3 (28 mg/m^2)"},{"description":"Non-progressed DIPG or H3K27M+ thalamic DMG patients received panobinostat orally every other day, 3 times per week at 36 mg/m\\^2/day for every other week (1course = 28 days) for up to 26 courses in the absence of disease progression or unacceptable toxicity.","id":"OG005","title":"Stratum 2, Dose Level 4 (36 mg/m^2)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who were evaluable for DLT assessment were included in this analysis. Of all 53 patients enrolled, 7 patients were not evaluable for DLT assessment: 4 patients received less than required dose of study drug, 2 patients did not start protocol therapy, and 1 patient had insufficient labs to monitor for DLTs.","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}