{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 The number of treated participants experiencing at least one of these adverse events as defined during the time of observation was counted.","groups":[{"description":"Participants received 3 cycles of induction with docetaxel, cisplatin and nivolumab (TPN) every 3 weeks (or 21 days): docetaxel 75 mg/m2 IV day 1, cisplatin 100 mg/m2 IV day 1, and nivolumab 240 mg IV flat dose day 1.\n\nInduction was followed by clinical and radiologic assessment of response. Participants without partial response or better based on RECIST 1.1 were offered salvage laryngectomy and/or pharyngectomy. Participants with partial or complete response per RECIST 1.1 proceeded with immunoradiotherapy concurrently with nivolumab. Intensity-modulated radiotherapy (IMRT) was preferred and proton beam radiotherapy not permitted. Nivolumab 240 mg IV flat dose day 1 was repeated every 2 weeks concurrently with IMRT (for a total of 3-4 doses).\n\nParticipants then received adjuvant nivolumab (480 mg IV flat dose day 1) every 4 weeks within 3-8 weeks from the last day of IMRT for up to 6 cycles or until disease progression or recurrence.","id":"OG000","title":"Induction Docetaxel (T)+Cisplatin (P)+Nivolumab (N) Then Radioimmunotherapy (IMRT+N) Then Adjuvant N"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"AEs were evaluated up to 9.6 months, representing maximum treatment duration for this study cohort.","title":"Number of Participants With Grade 3-5 Treatment-related Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}