TABLE 3.

Baseline demographics and disease characteristics

ECOG performance status and overall disease classification are based on assessments at baseline.

	No. (%) of patients
	Normal Hepatic Function (n = 10)	Mild Hepatic Impairment (n = 7)	Moderate Hepatic Impairment (n = 5)	Othera (n = 8)	Total (n = 30)
Age (y), median (range)	62.0 (56, 73)	70.0 (57, 79)	57.0 (52, 67)	64.5 (51, 78)	61.0 (51, 79)
Sex, n (%)
Male	4 (40)	6 (86)	5 (100)	2 (25)	17 (57)
Female	6 (60)	1 (14)	0	6 (75)	13 (43)
Race, n (%)
White	9 (90)	7 (100)	4 (80)	8 (100)	28 (93)
Black or African American	1 (10)	0	0	0	1 (3)
Asian	0	0	1 (20)	0	1 (3)
Smoking status, n (%)
Former	3 (30)	5 (71)	4 (80)	2 (25)	14 (47)
Never	6 (60)	1 (14)	1 (20)	4 (50)	12 (40)
Current	1 (10)	1 (14)	0	2 (25)	4 (13)
ECOG PS, n (%)
0	4 (40)	5 (71)	1 (20)	2 (25)	12 (40)
1	6 (60)	2 (29)	4 (80)	6 (75)	18 (60)
Primary tumor location, n (%)
Liver	0	6 (86)	2 (40)	1 (13)	9 (30)
Lung	3 (30)	0	1 (20)	1 (13)	6 (20)
Cervix	1 (10)	0	0	1 (13)	2 (7)
Head and neck (including nasopharynx, larynx, trachea)	1 (10)	0	1 (20)	0	2 (7)
Prostate	1 (10)	0	0	1 (13)	2 (7)
Other	1 (10)	0	0	1 (13)	1 (3)
Breast	0	0	0	1 (13)	1 (3)
Buccal	0	1 (14)	0	0	1 (3)
Colon	0	0	1 (20)	0	1 (3)
Ovary	1 (10)	0	0	0	1 (3)
Pancreas	0	0	0	1 (13)	1 (3)
Rectal	1 (10)	0	0	0	1 (3)
Renal	1 (10)	0	0	0	1 (3)
Overall disease classification
Metastaticb	7 (70)	4 (57)	5 (100)	7 (88)	23 (77)
Locally advancedc	3 (30)	3 (43)	0	1 (13)	7 (23)

ECOG, Eastern Cooperative Oncology Group; PS, performance status.

^aPatients not meeting inclusion criteria for a protocol-defined hepatic impairment group.

^bMetastatic disease: patient has any metastatic site of disease.

^cLocally advanced: patient has only locally advanced sites of disease.