TABLE 1.

Patient Characteristics

	No. of Patients (%)
	Dalantercept Dose
Characteristic	80 mg, N = 2	0.6 mg/kg, N = 13	1.2 mg/kg, N = 31	Overall, N = 46
Age: Median [range], y	56.5 [47–66]	60 [50–68]	61 [45–78]	60.5 [45–78]
Sex
Men	0 (0)	13 (100)	26 (83.9)	39 (84.8)
Women	2 (100)	0 (0)	5 (16.1)	7 (15.2)
ECOG PS
0	0 (0)	6 (46.2)	9 (29)	15 (32.6)
1	2 (100)	7 (53.8)	22 (71)	31 (67.4)
Site of primary tumor
Oropharynx	0 (0)	11 (84.6)	10 (32.3)	21 (45.7)
Oral cavity	2 (100)	2 (15.4)	11 (35.5)	15 (32.6)
Larynx	0 (0)	0 (0)	6 (19.4)	6 (13)
Unknown	0 (0)	0 (0)	4 (12.9)	4 (8.7)
HPV status
Positive	0 (0)	9 (69.2)	12 (38.7)	21 (45.7)
Negative	2 (100)	4 (30.8)	13 (41.9)	19 (41.3)
Unknown	0 (0)	0 (0)	6 (19.4)	6 (13)
Smoking status
Current	0 (0)	1 (7.7)	1 (3.2)	2 (4.3)
Former	1 (50)	6 (46.2)	23 (74.2)	30 (65.2)
Never	1 (50)	6 (46.2)	7 (22.6)	14 (30.4)
No. of prior regimens Median [range]	3 [3–3]	2 [1–8]	2 [1–6]	2 [1–8]
Prior radiotherapy to metastatic disease	0 (0)	3 (23.1)	11 (35.5)	14 (30.4)

Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; HPV, human papillomavirus.