Table 4.

Most common adverse events and treatment-related events

	Erlotinib and Fulvestrant (n=67)		Erlotinib Alone (n=33)		*P value (All Grades)
Any Adverse Event	All Grades (%)	Grade 3/4 (%)	All Grades (%)	Grade 3/4 (%)
Anorexia	22 (33)	2 (3)	10 (30)	1 (3)	0.799
Diarrhea	30 (45)	3 (5)	16 (49)	2 (6)	0.726
Dyspnea	22 (33)	5 (8)	6 (18)	3 (9)	0.125
Fatigue	29 (43)	3 (5)	12 (36)	1 (3)	0.508
Infection	16 (24)	6 (9)	5 (15)	1 (3)	0.314
Nausea	13 (19)	2 (3)	9 (27)	0 (0)	0.372
Pain	38 (57)	7 (10)	15 (46)	2 (6)	0.289
Rash	44 (66)	4 (6)	15 (46)	0 (0)	0.053
Treatment Related Adverse Event	All Grades (%)	Grade 3/4 (%)	All Grades (%)	Grade 3/4 (%)
Anorexia	17 (25)	2 (3)	9 (27)	1 (3)	0.839
Diarrhea	29 (43)	3 (5)	13 (39)	2 (6)	0.711
Fatigue	22 (33)	3 (5)	6 (18)	0 (0)	0.129
Nausea	10 (15)	1 (2)	8 (24)	0 (0)	0.254
Pain	15 (22)	1 (2)	9 (27)	0 (0)	0.591
Rash	44 (66)	15 (46)	15 (46)	0 (0)	0.053

^*Fisher’s exact test.

Most common adverse events were defined as those that occurred in at least 25% of patients