Safety
gastroenteritis, diarrhea, TRAEs, colitis
INTERSTITIAL LUNG DISEASE, GASTROENTERITIS, COLITIS
AEs of any cause occurred in 100 and 90.9% of patients in the nivolumab and placebo groups with Grade 3 or higher AEs in 55.6 and 22.7% of patients, respectively (In three patients, TRAEs (one patient with interstitial lung disease, one patient with diarrhea and one patient with colitis, gastroenteritis and white blood cell decreased) were treated with systemic steroids at doses of over 40 mg. One patient experienced Grade 3 interstitial lung disease more than 30 days after discontinuation of nivolumab and was treated with a systemic steroid at a dose of over 40 mg, which is not included in Summary of adverse eventsValues are 