{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Lymphocyte Count Decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Aspartate Aminotransferase increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Anorexia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Alanine Aminotransferase Increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Weight Loss"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Adrenal Insufficiency"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Rash maculo-papular"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Alkaline Phosphatase Increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Colitis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Mucositis oral"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hypokalemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Hypophosphatemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Serum Amylase Increased"}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"}],"units":"Participants"}],"description":"Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.","groups":[{"description":"Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity.\n\nNivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks.\n\nIpilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes).\n\nOn days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab.\n\nPatients will be assessed for response every 12 weeks (±7 days).","id":"OG000","title":"Nivolumab + Ipilimumab"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Up to 30 days after discontinuation, where range of cycles attempted was 1-11, where 1 Cycle = 84 days/12 weeks","title":"Number of Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5","type":"SECONDARY","unitOfMeasure":"Participants"}