an increasing trendP = 0.042
By the Cochrane-Armitage test, there was evidence of an increasing trend in the proportion of participants experiencing a grade 3–5 AE ( P = 0.042) by tertile of AUC ( P = 0.022) and in the proportion of participants experiencing any SAE by tertile of AUC ( P = 0.011; Tables 2 and 3 ).