Table 1. Patient Demographics and Clinical Characteristics.

This table describes the baseline demographics of the patients included in analysis for efficacy.

		Overall	Arm A (Docetaxel)	Arm B (Pulse Dose AT-101)	Arm C (Metronomic AT-101)
Age	n	35	13	11	11
	Mean	57	56.1	56.2	59
	Median (range)	57.2 (34–75)	57.2 (34–75)	56.4 (38–67)	58.3 (41–74)
Gender, n (%)	Male	29	11	9	9
	Female	6	2	2	2
ECOG Performance Status, n(%)	0 (Fully functional)	12	6	3	3
	1 (Minor Impairment)	19	6	6	7
	Unknown	4	1	2	1
Disease Primary Site	Oral Cavity	10	3	2	5
	Oropharynx	12	5	4	3
	Larynx	8	3	2	3
	Hypopharynx	1	0	1	0
	Nasopharynx	1	1	0	0
	Maxillary Sinus	1	0	1	0
	Orbit	1	1	0	0
	Unknown	1	0	1	0
Strata for Disease State	Locally advanced/recurrent	13	5	4	4
	Metastatic	22	8	7	7
Disease Extent at Enrollment, n (%)	Locoregional Only	11	5	4	2
	Distant Only	14	5	5	4
	Both Locoregional and Distant	10	3	2	5
HPV	Positive	11 (31%)	4 (31%)	4 (36%)	3 (27%)
	Negative	16 (46%)	5 (38%)	4 (36%)	7 (64%)
	Unknown	8 (23%)	4 (31%)	3 (27%)	1 (9%)
Prior Treatment Types	Prior Surgery	21	9	6	6
	Prior Radiation Therapy	34	13	10	11
	Prior Chemotherapy	32	13	9	10
Prior Treatment Modalities	Radiation	1	0	1	0
	Chemotherapy and Radiation	13	4	4	5
	Surgery and Chemotherapy	1	0	1	0
	Surgery and Radiation	2	0	1	1
	Surgery and Chemotherapy and Radiation	18	9	4	5
Lines of Chemotherapy	0 lines	3	0	2	1
	1 line	17	7	5	5
	2 lines	6	1	2	3
	3 lines	7	4	2	1
	4 lines	2	1	0	1
Any Exposure to Platinum Therapy		32	13	9	10
Exposure to Platinum Therapy (first occurance)	No platinum therapy	3	0	2	1
	First Line	29	10	9	10
	Second Line	1	1	0	0
	Third Line	2	2	0	0