Table 4.
Most Frequently (≥10% of Patients) Reported Adverse Events Occurring with Higher Frequency in the Combination Therapy Group (≥5% Difference Between Combination Group and Either Monotherapy Group) in Either WHO Functional Class II or III by Treatment Group
| Adverse Event, n (%)a | Combination Therapy (n = 253) | Ambrisentan Monotherapy (n = 126) | Tadalafil Monotherapy (n = 121) | |||
|---|---|---|---|---|---|---|
| FC II (n = 76) | FC III (n = 177) | FC II (n = 38) | FC III (n = 88) | FC II (n = 41) | FC III (n = 80) | |
| Any event | 74 (97) | 173 (98) | 35 (92) | 85 (97) | 38 (93) | 76 (95) |
| Headache | 39 (51) | 68 (38) | 8 (21) | 33 (38) | 14 (34) | 28 (35) |
| Edema peripheral | 34 (45) | 81 (46) | 12 (32) | 29 (33) | 12 (29) | 22 (28) |
| Nasal congestion | 22 (29) | 32 (18) | 8 (21) | 11 (13) | 5 (12) | 10 (13) |
| Nasopharyngitis | 15 (20) | 22 (12) | 6 (16) | 20 (23) | 6 (15) | 12 (15) |
| Cough | 13 (17) | 27 (15) | 5 (13) | 9 (10) | 7 (17) | 14 (18) |
| Dizziness | 13 (17) | 37 (21) | 6 (16) | 18 (20) | 4 (10) | 10 (13) |
| Pain in extremity | 13 (17) | 24 (14) | 4 (11) | 10 (11) | 4 (10) | 14 (18) |
| Flushing | 12 (16) | 26 (15) | 5 (13) | 13 (15) | 4 (10) | 7 (9) |
| Non-cardiac chest pain | 11 (14) | 16 (9) | 2 (5) | 8 (9) | 2 (5) | 6 (8) |
| Vomiting | 11 (14) | 17 (10) | 3 (8) | 8 (9) | 3 (7) | 9 (11) |
| Palpitations | 10 (13) | 18 (10) | 5 (13) | 15 (17) | 3 (7) | 14 (18) |
| Anemia | 9 (12) | 28 (16) | 1 (3) | 7 (8) | 5 (12) | 9 (11) |
| Bronchitis | 8 (11) | 19 (11) | 1 (3) | 4 (5) | 4 (10) | 6 (8) |
| Epistaxis | 8 (11) | 14 (8) | 1 (3) | 4 (5) | 4 (10) | 7 (9) |
| Dyspepsia | 6 (8) | 23 (13) | 0 | 5 (6) | 6 (15) | 8 (10) |
FC Functional class, WHO World Health Organization
aIncludes adverse events with onset between the first dose of study drug and last dose + 30 days