{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"228"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"142"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"27"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Grade 4"}],"denoms":[{"counts":[{"groupId":"OG000","value":"45"},{"groupId":"OG001","value":"43"}],"units":"Participants"}],"description":"Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.1. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product.\n\nA serious adverse event (SAE) is defined as any AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is to be deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement that may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.","groups":[{"description":"Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"OG000","title":"Phase I Lead in + Phase II: Cohort A"},{"description":"Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"OG001","title":"Phase II - Cohort B"}],"paramType":"NUMBER","populationDescription":"Evaluable participants","reportingStatus":"POSTED","timeFrame":"Up to 48 months","title":"Number of Study Treatment Related Adverse Events","type":"SECONDARY","unitOfMeasure":"events"}