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Table 1 Baseline demographics and clinical characteristics

From: A randomized, double-blind, placebo-controlled study of high-dose bosentan in patients with stage IV metastatic melanoma receiving first-line dacarbazine chemotherapy

Parameter Placebo +
dacarbazine
(n = 40)*
Bosentan +
dacarbazine
(n = 40)*
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)
  1. SD, standard deviation of the mean; ECOG, Eastern Cooperative Oncology Group; ULN, upper limit of normal (value set by each local site, as per their normal practice)
  2. * All-randomized set
  3. ** n = 39 (one patient missing randomization date; calculation of age not possible)
  4. † All-treated population; data not available for 2 patients in each group (due to consent withdrawal or randomization error)
  5. n = 37 (one patient missing)