|
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
