Table 4 Most frequent (≥5 %) adverse events during ambrisentan treatment (safety population) by maximum Intensity
Adverse events | Mild | Moderate | Severe | Total |
|---|---|---|---|---|
Any adverse events, n (%) | 52 (38.8) | 32 (23.9) | 7 (5.2) | 91 (67.9) |
Oedema peripheral | 10 (7.5) | 5 (3.7) | 0 | 15 (11.2) |
Flushing | 10 (7.5) | 1 (0.7) | 0 | 11 (8.2) |
Alanine aminotransferase increased | 8 (6.0) | 1 (0.7) | 0 | 9 (6.7) |
Aspartate aminotransferase increased | 7 (5.2) | 2 (1.5) | 0 | 9 (6.7) |
Blood bilirubin increased | 8 (6.0) | 1 (0.7) | 0 | 9 (6.7) |
Gamma-glutamyltransferase increased | 4 (3.0) | 3 (2.2) | 0 | 7 (5.2) |
Headache | 7 (5.2) | 0 | 0 | 7 (5.2) |
Nausea | 4 (3.0) | 3 (2.2) | 0 | 7 (5.2) |