Table 3.

Treatment-Emergent AEs of All Causality

AE	Tremelimumab (n = 325)*		Chemotherapy (n = 319)*
	No.	%	No.	%
Any AE	312	96	292	92
Any grade 3 or 4 AE	170	52	119	37
Any serious AE	121	37	50	16
Any grade 5 AE	22	7	13	4
Discontinued treatment because of AEs	43	13	10	3

AE	Tremelimumab (n = 325)*				Chemotherapy (n = 319)*
	Any Grade		Grade≥ 3		Any Grade		Grade≥ 3
	No.	%	No.	%	No.	%	No.	%
Treatment-emergent AE of any causality in ≥ 10% of patients
Diarrhea/colitis	166	51	60	18	56	18	6	2
Nausea	109	34	14	4	158	50	10	3
Fatigue	106	33	19	6	118	37	5	2
Rash	106	33	7	2	17	5	1	< 1
Pruritus	100	31	3	1	16	5	0	0
Vomiting	74	23	14	4	92	29	9	3
Decreased appetite	67	21	14	4	40	13	1	< 1
Thrombocytopenia	5	2	1	< 1	63	20	26	8
Pyrexia	53	16	4	1	27	9	0	0
Abdominal pain	68	21	12	4	35	11	3	1
Neutropenia	2	1	1	< 1	50	16	34	11
Constipation	48	15	2	1	102	32	2	1
Cough	48	15	1	< 1	28	9	0	0
Dyspnea	43	13	8	3	26	8	2	1
Headache	37	11	2	1	42	13	1	< 1
Weight decrease	36	11	1	< 1	10	3	1	< 1
Asthenia	0	0	0	0	34	11	5	2
Peripheral edema	32	10	5	2	18	6	1	< 1
Treatment-emergent AEs of special interest
Thyroid disorders	17	5	2	1	2	1	0	0
Hypothalamus and pituitary disorders	6	2	4	1	0	0	0	0
Adrenal insufficiency	4	1	3	1	0	0	0	0
Ocular infections, irritations, or inflammation	13	4	0	0	3	1	0	0
Hepatitis	2	1	2	1	0	0	0	0
Pancreatitis	3	1	3	1	0	0	0	0

Abbreviation: AE, adverse event.

^*Patients who were evaluable for AEs.