Table 5.
Most Frequent Adverse Events and Abnormal Laboratory Results in Patients Administered Macitentan 10 mg (n=9)
| Patients with ≥1 TEAEA | 9 (100) |
| Nasopharyngitis | 4 (44.4) |
| Angioplasty | 4 (44.4) |
| Fatigue | 2 (22.2) |
| Patients with serious TEAEB | 4 (44.4) |
| Patients with TEAEs leading to discontinuation of study treatment | 0 |
| Patients with special interest TEAE and abnormal laboratory results | |
| Blood pressure decrease | 1 (11.1) |
| Abnormal liver function test | 1 (11.1) |
| Anemia | 1 (11.1) |
| Edema | 1 (11.1) |
| Joint swelling | 1 (11.1) |
| Hypotension | 1 (11.1) |
| Hemoglobin decrease from baseline ≥20 and <50 g/L | 1 (11.1) |
Data are given as n (%). ATreatment-emergent adverse events (TEAEs) with ≥2 patients reported are listed. BAll serious TEAEs reported were angioplasty (hospitalization for balloon pulmonary angioplasty), performed on the same day or later than the date of macitentan discontinuation.