Table 2

Summary of AEs in patients with CTD-PAH and SSc-PAH (mITT population)

Number of patients with an AE, n (%)CTD-PAHSSc-PAH
Combination therapy
(n=117)
MonotherapyCombination therapy
(n=81)
Monotherapy
Ambrisentan
(n=52)
Tadalafil
(n=47)
Ambrisentan
(n=28)
Tadalafil
(n=28)
AEs*
Any AE116 (99)50 (96)45 (96)80 (99)27 (96)27 (96)
Peripheral oedema56 (48)20 (38)14 (30)37 (46)9 (32)9 (32)
Headache40 (34)18 (35)18 (38)24 (30)9 (32)10 (36)
Diarrhoea34 (29)17 (33)12 (26)23 (28)5 (18)9 (32)
Dizziness21 (18)15 (29)12 (26)13 (16)7 (25)7 (25)
Dyspnoea25 (21)12 (23)10 (21)20 (25)5 (18)6 (21)
Nausea21 (18)12 (23)11 (23)13 (16)6 (21)8 (29)
Arthralgia20 (17)7 (13)12 (26)10 (12)3 (11)4 (14)
Cough19 (16)5 (10)11 (23)13 (16)07 (25)
Serious AEs
Any serious AE53 (45)20 (38)24 (51)36 (44)12 (43)17 (61)
Pulmonary hypertension7 (6)4 (8)6 (13)4 (5)1 (4)5 (18)
Pneumonia10 (9)4 (8)3 (6)5 (6)4 (14)2 (7)
Dyspnoea4 (3)2 (4)2 (4)4 (5)1 (4)2 (7)
Anaemia5 (4)1 (2)3 (6)4 (5)1 (4)1 (4)
  • *AEs occurring in ≥25% of patients in any group.

  • †Serious AEs occurring in >4% of patients in any group.

  • AE, adverse event; CTD, connective tissue disease; mITT, modified intention to treat; PAH, pulmonary arterial hypertension; SSc, systemic sclerosis.