Table 1 Baseline demographics and clinical characteristics

Sex

   Male, n (%)

22 (55.0)

28 (70.0)

   Female, n (%)

18 (45.0)

12 (30.0)

Mean age ± SD, years

58.0 ± 14.8**

62.1 ± 12.2

ECOG performance status, n (%)

   0

29 (72.5)

27 (67.5)

   1

7 (17.5)

11 (27.5)

   2

4 (10.0)

2 (5.0)

Lactate dehydrogenase

Placebo +

dacarbazine

(n = 38) ^†

Bosentan +

dacarbazine

(n = 38) ^†

≤ ULN, n (%)

25 (67.5)^‡

26 (38.4)

> ULN, n (%)

12 (37.4)^‡

12 (31.5)

Mean ± SD, U/L

351 ± 199^‡

337 ± 178

Median [min, max], U/L

279 [99, 813]^‡

259 [129, 774]

Previous medications for stage I-III melanoma

Placebo +

dacarbazine

(n = 38) ^†

Bosentan +

dacarbazine

(n = 38) †

Any previous treatment, n (%)

9 (23.7)

9 (23.7)

   Immunostimulants

4 (10.5)

7 (18.4)

   Interferons

4 (10.5)

1 (2.6)

   Anti-neoplastic agents

1 (2.6)

1 (2.6)

   Other investigational drug

1 (2.6)

1 (2.6)