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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

From: Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension

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)
  1. FC Functional class, WHO World Health Organization
  2. aIncludes adverse events with onset between the first dose of study drug and last dose + 30 days