{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29"}]}],"title":"Grade 3-5 Adverse Events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Grade 3-5 Drug Related Adverse Events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"}],"units":"Participants"}],"description":"Safety will be assessed by quantifying the toxicities and grades experienced by subjects including serious AEs (SAEs) and events of clinical interest. Safety and tolerability will be assessed by clinical review of all relevant parameters including AEs, laboratory tests, vital signs, and electrocardiogram measurements. Assessed number of participants who experienced grade 3 to 5 adverse events.","groups":[{"description":"Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression\\* or unacceptable toxicity.\n\n\\* NOTE: Patients with confirmed disease progression may continue to receive treatment if they are otherwise clinically stable until there is an increase in tumor burden of 25% or more following initial confirmation of progression. Under exceptional circumstances, and with protocol P.I. and CITN P.I. approval, patients may receive treatment beyond 2 years.\n\nLaboratory Biomarker Analysis: Ancillary studies\n\nPembrolizumab: Given IV","id":"OG000","title":"Treatment (Pembrolizumab)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 90 days post-treatment","title":"Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0","type":"SECONDARY","unitOfMeasure":"Participants"}