Table 4.

Effect of treatment on adverse events by overall cohort and baseline kidney function category^a

Adverse Event	Rate of Adverse Event (n/N [%])	Treatment Effect (OR [95% CI])	P for Interaction between Treatment and Kidney Function Category
Had a serious adverse event
overall cohort	1728/7316 (23.6)	0.89 (0.79 to 1.00)
category of CrCl (ml/min)
<45	436/1480 (29.5)	0.90 (0.71 to 1.13)	0.726
45 to 59	786/3493 (22.5)	0.86 (0.73 to 1.02)
≥60	506/2343 (21.6)	0.94 (0.76 to 1.16)
category of eGFR (ml/min)
<45	117/343 (34.1)	0.78 (0.49 to 1.23)	0.388
45 to 59	928/3921 (23.7)	0.87 (0.75 to 1.02)
≥60	683/3052 (22.4)	0.94 (0.79 to 1.12)
Discontinued because of an adverse event
overall cohort	716/7316 (9.8)	1.18 (1.00 to 1.39)
category of CrCl (ml/min)
<45	167/1480 (11.3)	1.02 (0.72 to 1.43)	0.423
45 to 59	354/3493 (10.1)	1.24 (0.97 to 1.57)
≥60	195/2343 (8.3)	1.24 (0.90 to 1.71)
category of eGFR (ml/min)
<45	53/343 (15.5)	0.61 (0.34 to 1.09)	0.337
45 to 59	382/3921 (9.7)	1.32 (1.04 to 1.67)
≥60	281/3052 (9.2)	1.18 (0.90 to 1.53)
Discontinued because of an adverse event or death
overall cohort	776/7316 (10.6)	1.15 (0.98 to 1.35)
category of CrCl (ml/min)
<45	191/1480 (12.9)	1.02 (0.74 to 1.41)	0.610
45 to 59	379/3493 (10.9)	1.23 (0.97 to 1.55)
≥60	206/2343 (8.8)	1.15 (0.85 to 1.57)
category of eGFR (ml/min)
<45	61/343 (17.8)	0.65 (0.37 to 1.13)	0.460
45 to 59	410/3921 (10.5)	1.30 (1.03 to 1.63)
≥60	305/3052 (10.0)	1.13 (0.88 to 1.45)

^aSerious adverse event is defined as an adverse event that resulted in death, hospitalization, cancer, permanent disability, or threat to life; women were counted only once, even when they had more than one serious adverse event.