{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}],"title":"Grade 3+ Adverse Event"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"Grade 4+ Adverse Event"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"}],"units":"Participants"}],"description":"The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. The number of patients reporting a grade 3+ adverse event regardless of attribution is reported here.","groups":[{"description":"Participants received avelumab IV over 60 minutes every 14 days for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Beginning 29 days after the first dose of avelumab, participants received 35 mg/m\\^2/day cisplatin IV starting on day 1 of courses 3-5 for up to 6 weeks in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Avelumab and Cisplatin IV"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All patients who were registered, received protocol treatment, and were assessed for adverse events were included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to 12 months","title":"Adverse Events Per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0)","type":"SECONDARY","unitOfMeasure":"Participants"}