Table 2.
Incidence of NCI-CTCAEs up to one day post study treatment (all-treated population)
| 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) | - |
AE, adverse event
* ≥ 10% frequency in bosentan + dacarbazine group; **one patient had a Grade 5 event (metastatic malignant melanoma/malignant neoplasm progression); †data missing for one patient