Table 3.

Adverse Events of Interest.^*

Adverse Event	dMMR Cohort (N = 215)				pMMR Cohort (N = 550)
	Pembrolizumab (N = 109)		Placebo (N = 106)		Pembrolizumab (N = 276)		Placebo (N = 274)
	Any Grade	Grade ≥3	Any Grade	Grade ≥3	Any Grade	Grade ≥3	Any Grade	Grade ≥3
number of patients (percentage
Any event	42 (38.5)	9 (8.3)	28 (26.4)	6 (5.7)	92 (33.3)	10 (3.6)	54 (19.7)	7 (2.6)
Infusion reaction	16 (14.7)	4 (3.7)	16 (15.1)	3 (2.8)	41 (14.9)	4 (1.4)	35 (12.8)	5 (1.8)
Hypothyroidism	14 (12.8)	0	10 (9.4)	0	37 (13.4)	0	7 (2.6)	0
Hyperthyroidism	10 (9.2)	0	1 (0.9)	0	16 (5.8)	0	10 (3.6)	0
Colitis	7 (6.4)	0	0	0	4 (1.4)	0	4 (1.5)	1 (0.4)
Pneumonitis	3 (2.8)	2 (1.8)	2 (1.9)	1 (0.9)	2 (0.7)	0	1 (0.4)	0
Glucose intolerance	2 (1.8)	0	0	0	0	0	0	0
Acute kidney injury	2 (1.8)	2 (1.8)	2 (1.9)	2 (1.9)	5 (1.8)	5 (1.8)	1 (0.4)	1 (0.4)
Hepatic failure	1 (0.9)	1 (0.9)	0	0	0	0	0	0
Myositis	1 (0.9)	0	1 (0.9)	0	1 (0.4)	0	0	0
Hypophysitis	0	0	0	0	2 (0.7)	2 (0.7)	0	0
Pancreatitis	0	0	0	0	1 (0.4)	0	0	0
Adrenal insufficiency	0	0	0	0	4 (1.4)	0	1 (0.4)	0

^*The events of interest are those with a possible immune-related cause and are considered regardless of attribution by the investigator. Some patients may have had more than one adverse event of interest. The events are listed in descending order of frequency in the pembrolizumab group in the dMMR cohort.