Table 3 Summary of safety (safety population): post-hoc analysis
Ambrisentan | ||
|---|---|---|
CTD-PAH (N = 71) | IPAH/HPAH (N = 51) | |
Any AEs, n (%) | 52 (73.2) | 31 (60.8) |
AEs related to study treatment | 28 (39.4) | 17 (33.3) |
Discontinuation due to AE | 1 (1.4) | 2 (3.9) |
Any serious AEs, n (%) | 6 (8.5) | 3 (5.9) |
Deaths, n (%) | 1 (1.4) | 1 (2.0) |
Most frequent (≥5% in either subgroup) AEs, n (%) | ||
Flushing | 9 (12.7) | 2 (3.9) |
Oedema peripheral | 7 (9.9) | 8 (15.7) |
Headache | 6 (8.5) | 0 |
Decreased appetite | 5 (7.0) | 1 (2.0) |
Dizziness | 5 (7.0) | 1 (2.0) |
Nausea | 5 (7.0) | 2 (3.9) |
Alanine aminotransferase increased | 4 (5.6) | 5 (9.8) |
Blood bilirubin increased | 4 (5.6) | 5 (9.8) |
Blood glucose increased | 2 (2.8) | 3 (5.9) |
Cough | 4 (5.6) | 2 (3.9) |
Gamma glutamyltransferase increased | 4 (5.6) | 3 (5.9) |
Aspartate aminotransferase increased | 3 (4.2) | 6 (11.8) |