Table 3.

Most Common Treatment-Related Adverse Events Seen in LUX-Lung 8*.

	Afatinib (n=392)				Erlotinib (n=395)
	Grade 1	Grade 2	Grade 3	Grade 4	Grade 1	Grade 2	Grade 3	Grade 4
Diarrhea	165 (42%)	68 (17%)	39 (10%)	2 (<1%)	94 (24%)	28 (7%)	9 (2%)	1 (<1%)
Rash or acne†	157 (40%)	83 (21%)	23 (6%)	0 (0%)	142 (36%)	83 (21%)	41 (10%)	0 (0%)
Stomatitis†	65 (17%)	32 (8%)	16 (4%)	0 (0%)	21 (5%)	13 (3%)	0 (0%)	0 (0%)
Fatigue†	33 (8%)	20 (5%)	6 (2%)	0 (0%)	24 (6%)	17 (4%)	7 (2%)	0 (0%)
Nausea	35 (9%)	13 (3%)	4 (1%)	0 (0%)	20 (5%)	5 (1%)	3 (<1%)	0 (0%)
Decreased appetite	31 (8%)	16 (4%)	3 (<1%)	0 (0%)	24 (6%)	15 (4%)	2 (<1%)	0 (0%)
Paronychia†	28 (7%)	11 (3%)	2 (<1%)	0 (0%)	9 (2%)	7 (2%)	1 (<1%)	0 (0%)
Dry skin	28 (7%)	4 (1%)	2 (<1%)	0 (0%)	34 (9%)	7 (2%)	0 (0%)	0 (0%)
Pruritus	22 (6%)	9 (2%)	1 (<1%)	0 (0%)	37 (9%)	10 (3%)	0 (0%)	0 (0%)
Vomiting	20 (5%)	8 (2%)	3 (<1%)	0 (0%)	7 (2%)	4 (1%)	2 (<1%)	0 (0%)
Dehydration	2 (<1%)	5 (1%)	3 (<1%)	4 (1%)	0 (0%)	0 (0%)	3 (<1%)	0 (0%)

Notes: *Includes grade 1–2 adverse events that occurred in >10% of patients, or grade 3–5 adverse events that occurred in >1% patients within any treatment group. ^†Grouped term. Reprinted from The Lancet Oncology, Vol 16, Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial, pp. 897–907, Copyright (2015), with permission from Elsevier.58