{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"description":"Safety as the percentage of patients in Phase 1 (ipilimumab monotherapy) of the study, who experienced dose-limiting toxicities (DLTs) or serious adverse events (SAEs), using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.","groups":[{"description":"Participants receive ipilimumab intratumorally on Day 1\n\nIpilimumab: Given intratumorally","id":"OG000","title":"Ipilimumab 25 mg"},{"description":"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions\n\nIpilimumab: Given intratumorally\n\nRadiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions","id":"OG001","title":"Ipilimumab 25 mg and Radiation Therapy"}],"paramType":"NUMBER","populationDescription":"This study did not proceed to Phase 2 (ipilimumab plus radiation combination therapy).","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Dose-limiting Toxicity","type":"PRIMARY","unitOfMeasure":"percentage of participants"}