Table 2.

Adverse events reported in the study and management

AEs		Grades according to CTCAE v4.0										Action required for the AE management
Elderly patients	younger patients	Grade 1		Grade 2		Grade 3		Grade 4		Grade 5		Hospitalization		Invasive procedure		Systemic corticosteroids		Additive immunosuppressive therapy
		E	Y	E	Y	E	Y	E	Y	E	Y	E	Y	E	Y	E	Y	E	Y
Skin reaction		5	7	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asthenia		4	2	0	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nausea		1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Hypereosinophilia		1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypophysitis		0	0	0	0	1	2	0	0	0	0	1	0	0	0	1	2	0	0
Colitis		0	0	1	0	1	1	0	1	0	0	1	1	1	2	2	2	1	1
Hepatitis		0	0	0	0	2a	0	0	0	0	0	2	0	2	0	2	0	1	0
Pneumopathy		0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0
Severe infection		0	0	0	0	0	0	0	0	1a	0	1	0	0	0	0	0	0	0
Total n (%)		11 (48)	9 (43)	6 (26)	7 (33)	5 (22)	4 (19)	0	1 (5)	1 (4)	0	b5 (22)	2 (9)	c4 (17)	2 (9)	d5 (22)	4 (19)	e2 (9)	1 (4)
p value (Fisher’s exact test)		0.44		1.00		0.72		1.00		0.45		0.24		0.40		0.72		0.58

^aAEs observed in patients previously treated with PD1 inhibitor in a sequential treatment

^bHospitalization: in elderly group (median 32 days, [4; 64]) was required for 4 patients (including 1 patient for 2 successive AEs)/in younger group (median 17 days, [10; 24])

^cInvasive procedures were: in elderly group: rectosigmoidoscopy (n = 1), liver biopsy (n = 2), bronchial fibroscopy (n = 1)/in younger group: rectosigmoidoscopy (n = 2)

^dFive patients needed systemic corticosteroids (including 1 patient for 2 successive AEs)

^eAdditive immunosuppressive therapy: in elderly group: mycophenolate mofetil (n = 1), infliximab (n = 1)/in younger group: infliximab (n = 1)