Table 3.

Adverse events of any cause

	ECOG PS 0/1 (n = 114)		ECOG PS 2 (n = 3)		All patients (n = 117)
Adverse event, n (%)	Any gradea	Grade 3 or 4	Any grade	Grade 3 or 4	Any gradea	Grade 3 or 4
Cough	43 (37.7)	0	2 (66.7)	0	45 (38.5)	0
Asthenia	29 (25.4)	0	2 (66.7)	0	31 (26.5)	0
Dyspnea	27 (23.7)	1 (0.9)	2 (66.7)	0	29 (24.8)	1 (0.9)
Arthralgia	23 (20.2)	1 (0.9)	1 (3.3)	0	24 (20.5)	1 (0.9)
Diarrhea	24 (21.2)	0	0	0	24 (20.5)	0
Fatigue	24 (21.1)	0	0	0	24 (20.5)	0
Constipation	23 (20.2)	0	0	0	23 (19.7)	0
Pneumonitis	21 (18.4)	2 (1.8)	1 (33.3)	0	22 (18.8)	2 (1.7)
Pyrexia	22 (19.3)	1 (0.9)	0	0	22 (18.8)	1 (0.9)
Pruritus	19 (16.7)	0	2 (66.7)	0	21 (17.9)	0
Headache	17 (14.9)	1 (0.9)	1 (33.3)	0	18 (15.4)	1 (0.9)
Back pain	17 (14.9)	0	0	0	17 (14.5)	0
Nausea	17 (14.9)	0	0	0	17 (14.5)	0
Hypothyroidism	15 (13.2)	1 (0.9)	1 (33.3)	0	16 (13.7)	1 (0.9)
Non-cardiac chest pain	15 (13.2)	0	1 (33.3)	0	16 (13.7)	0
Decreased appetite	14 (12.3)	0	1 (33.3)	0	15 (12.8)	0
Rash	13 (11.4)	0	1 (33.3)	0	14 (12.0)	0
Pneumonia	13 (11.4)	5 (4.4)	0	0	13 (11.1)	5 (4.3)
Hyperthyroidism	12 (10.5)	0	0	0	12 (10.3)	0
Hypertension	7 (6.1)	3 (2.6)	1 (33.3)	0	8 (6.8)	3 (2.6)
Pulmonary embolism	4 (3.5)	3 (2.6)	0	0	4 (3.4)	3 (2.6)

Tabulated AE terms are limited to those reported in at least 10% of all patients at any grade or at least 2% of all patients at a maximum grade of 3 or 4 (as graded as per CTCAE version 4.03).

AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; ECOG PS, Eastern Cooperative Oncology Group performance status.

^aThree patients had grade 5 AEs (all were in the ECOG PS 0/1 cohort); the events were pulmonary sepsis, cardiac arrest, and pneumonitis (n = 1 each).