{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"DLTs were defined as adverse events (AE) at least possibly attributed to APX005M that occurred during the first 2 courses (6 weeks) following APX005M administration. DLTs included any APX005M-related AE that led to dose reduction or permanent cessation of therapy or resulted in a treatment delay \\>2 weeks. Hematologic DLTs included grade 3 neutropenia with fever, any grade 4 hematologic toxicity except lymphopenia, and grade 3 thrombocytopenia on 2 separate days or requiring platelet transfusion on 2 days within a 7-day period. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, grade 3 or higher cytokine release syndrome, or any grade 3 non-hematologic toxicity with some exceptions such as grade 3 nausea/vomiting \\<5 days or grade 3 diarrhea that responded to treatment within 5 days.","groups":[{"description":"Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.1 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.","id":"OG000","title":"Stratum 1, Dose Level 1"},{"description":"Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.","id":"OG001","title":"Stratum 1, Dose Level 2"},{"description":"Patients with recurrent or refractory primary malignant CNS tumors received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.","id":"OG002","title":"Stratum 1, Dose Level 3"},{"description":"Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.3 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.","id":"OG003","title":"Stratum 2, Dose Level 2"},{"description":"Patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG) received APX005M on day 1 of each 21-day course at 0.6 mg/kg for up to 36 courses or until disease progression, unacceptable toxicity, or death.","id":"OG004","title":"Stratum 2, Dose Level 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients who were evaluable for DLT assessment were included in this analysis. Of 31 eligible patients enrolled, 2 patients were not evaluable for DLT assessment due to early disease progression (received less than 2 doses of therapy).","reportingStatus":"POSTED","timeFrame":"6 weeks","title":"Number of Patients Who Experienced Dose-limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}