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Table 2 Incidence of NCI-CTCAEs up to one day post study treatment (all-treated population)

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

  Placebo + dacarbazine
(n = 38)
Bosentan + dacarbazine
(n = 38)
Event Any grade Grade 3 Grade 4 Any grade Grade 3 Grade 4
Patients with at least one AE, n (%) 37 (97.4) 9 (23.7) 1 (2.6) 38 (100)** 14 (36.8) 1 (2.6)
Patients with AE,* n (%)       
   Nausea 19 (50.0) - - 22 (57.9) 1 (2.6) -
   Fatigue 19 (50.0) - - 14 (36.8) 2 (5.3) -
   Constipation 10 (26.3) - - 12 (31.6) - -
   Vomiting 8 (21.1) - - 12 (31.6) 2 (5.3) -
   Thrombocytopenia 4 (10.5) 1 (2.6) - 9 (23.7) 2 (5.3) 1 (2.6)
   Headache 11 (28.9) 1 (2.6) - 7 (18.4) - -
   Anemia 1 (2.6) - - 7 (18.4) 2 (5.3) 1 (2.6)
   Anorexia 7 (18.4) - - 6 (15.8) - -
   Diarrhea 7 (18.4) - - 6 (15.8) - -
   Neutropenia 5 (13.2) 2 (5.3) 1 (2.6) 6 (15.8) 5 (13.2) -
   Lethargy 2 (5.3) - - 6 (15.8) - -
   Dyspnea 9 (23.7) 3 (7.9) - 5 (13.2) 2 (5.3) -
   Cough 6 (15.8) - - 5 (13.2) - -
   Pain in extremity 4 (10.5) 1 (2.6) - 5 (13.2) 1 (2.6) -
   Edema peripheral 3 (7.9) - - 5 (13.2)† - -
   Insomnia 5 (13.2) - - 4 (10.5) - -
Alanine aminotransferase
increased
3 (7.9) - - 4 (10.5) 1 (2.6) -
  1. AE, adverse event
  2. * ≥ 10% frequency in bosentan + dacarbazine group; **one patient had a Grade 5 event (metastatic malignant melanoma/malignant neoplasm progression); †data missing for one patient