{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).","groups":[{"description":"Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2"},{"description":"Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.","reportingStatus":"POSTED","timeFrame":"From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)","title":"Number of Participants Who Had Dose Limiting Toxicities","type":"PRIMARY","unitOfMeasure":"Participants"}