Table 4 Most frequent on-treatment AEs by preferred term (ITT population)
From: Randomised trial of once-daily vilanterol in children with asthma on inhaled corticosteroid therapy
AE (preferred term), n (%) | Placebo | VI 6.25 μg | VI 12.5 μg | VI 25 μg |
|---|---|---|---|---|
N = 115 | N = 114 | N = 113 | N = 114 | |
Children with any AE | 25 (22) | 33 (29) | 37 (33) | 32 (28) |
Children with most frequent events | 15 (13) | 27 (24) | 26 (23) | 18 (16) |
Nasopharyngitis | 8 (7) | 8 (7) | 10 (9) | 9 (8) |
Headache | 4 (3) | 6 (5) | 2 (2) | 2 (2) |
Rhinitis | 3 (3) | 2 (2) | 3 (3) | 1 (<1) |
Respiratory tract infection viral | 1 (<1) | 3 (3) | 2 (2) | 1 (<1) |
Rhinitis allergic | 0 | 2 (2) | 3 (3) | 2 (2) |
Abdominal pain | 1 (<1) | 0 | 3 (3) | 2 (2) |
Bronchitis | 2 (2) | 3 (3) | 1 (<1) | 0 |
Pharyngitis | 1 (<1) | 3 (3) | 0 | 2 (2) |
Influenza | 0 | 4 (4) | 0 | 0 |
Ear pain | 0 | 0 | 3 (3) | 0 |