Table 1.
Safety findings in the AMBITION [11] trial
| Ambrisentan and tadalafil combination therapy (n = 253) | Ambrisentan monotherapy (n = 126) | Tadalafil monotherapy (n = 121) | |
|---|---|---|---|
| Most common AEs (≥ 10% in any group), n (%) | |||
| Peripheral edema | 115 (45) | 41 (33) | 34 (28) |
| Headache | 107 (42) | 41 (33) | 42 (35) |
| Nasal congestion | 54 (21) | 19 (15) | 15 (12) |
| Diarrhea | 50 (20) | 29 (23) | 23 (19) |
| Dizziness | 50 (20) | 24 (19) | 14 (12) |
| Dyspnea | 44 (17) | 22 (17) | 20 (17) |
| Nausea | 43 (17) | 18 (14) | 20 (17) |
| Cough | 40 (16) | 14 (11) | 21 (17) |
| Flushing | 38 (15) | 18 (14) | 11 (9) |
| Anemia | 37 (15) | 8 (6) | 14 (12) |
| Nasopharyngitis | 37 (15) | 26 (21) | 18 (15) |
| Pain in extremity | 37 (15) | 14 (11) | 18 (15) |
| URTI | 34 (13) | 20 (16) | 20 (17) |
| Arthralgia | 32 (13) | 17 (13) | 19 (16) |
| Back pain | 31 (12) | 13 (10) | 18 (15) |
| Fatigue | 30 (12) | 17 (13) | 15 (12) |
| Dyspepsia | 29 (11) | 5 (4) | 14 (12) |
| Palpitations | 28 (11) | 20 (16) | 17 (14) |
| Vomiting | 28 (11) | 11 (9) | 12 (10) |
| Bronchitis | 27 (11) | 5 (4) | 10 (8) |
| Non-cardiac chest pain | 27 (11) | 10 (8) | 8 (7) |
| Myalgia | 23 (9) | 12 (10) | 15 (12) |
| UTI | 18 (7) | 9 (7) | 15 (12) |
| Pulmonary hypertension | 12 (5) | 13 (10) | 9 (7) |
| AEs leading to treatment discontinuation, n (%) | 31 (12) | 14 (11) | 14 (12) |
Primary analysis set, on randomized treatment
AE adverse event, URTI upper respiratory tract infection, UTI urinary tract infection