{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"}],"units":"Participants"}],"description":"To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN).\n\nNumber of participants affected by AEs will be reported by grade and percentage of participants affected.\n\nSafety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.","groups":[{"description":"Pembrolizumab + Cisplatin + Radiation\n\npembrolizumab (MK-3475): 200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.\n\nCisplatin: Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36\n\nRadiation: 70 Gy fractionated over 35 days","id":"OG000","title":"Single Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Number of participants who experience an Adverse Event.","reportingStatus":"POSTED","timeFrame":"through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment)","title":"Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided.","type":"PRIMARY","unitOfMeasure":"Participants"}