Table 1.

Summary of baseline characteristics*

	Overall			Rash subgroup
	Erlotinib (N=350)	Placebo (N=320)	p Value	Erlotinib (N=178)	Placebo (N=278)	p Value
Age
Median	77	78	0.899	78	78	0.991
Range	(45–91)	(51–91)		(51–91)	(45–91)
Gender
Female	135 (39%)	126 (39%)	0.833	69 (39%)	108 (39%)	0.984
Male	215 (61%)	194 (61%)	0.834	109 (61%)	170 (61%)	0.983
ECOG
0–1	54 (15%)	53 (16%)	0.692	37 (21%)	50 (18%)	0.459
2	194 (55%)	185 (56%)	0.539	103 (58%)	165 (59%)	0.756
3	102 (25%)	90 (27%)	0.771	38 (21%)	63 (23%)	0.741
Cell type
Adenocarcinoma	133 (38%)	123 (38%)	0.908	63 (35%)	103 (37%)	0.718
Large cell	15 (4%)	15 (5%)	0.801	7 (4%)	15 (5%)	0.477
Squamous	136 (39%)	127 (40%)	0.825	75 (42%)	114 (41%)	0.810
Other NSCLC	66 (19%)	55 (17%)	0.574	33 (19%)	46 (17%)	0.582
Smoking status
Smoker	124 (35%)	119 (37%)	0.631	43 (24%)	104 (37%)	0.003
Ex-smoker	207 (59%)	183 (57%)	0.608	122 (69%)	158 (57%)	0.012
Never smoked	19 (5%)	18 (6%)	0.911	13 (7%)	16 (6%)	0.509

*Only those patients who took study drug were included in the analysis.

ECOG, Eastern Cooperative Oncology Group; NSCLC, non-small cell lung cancer.