Table 5 Occurrence of all adverse events (AEs) and most frequent on-treatment AEs, ITT population
Number (%) of patients | |||
|---|---|---|---|
VI 25 mcg OD (N = 115) | SAL 50 mcg BD (N = 116) | Placebo (N = 116) | |
Any AE | 55 (48) | 48 (41) | 47 (41) |
Treatment-related AE | 2 (2) | 4 (3) | 5 (4) |
AE leading to withdrawal | 2 (2) | 2 (2) | 3 (3) |
Any serious AE | 1 (<1) | 0 (0) | 1 (<1) |
Any fatal AE | 0 (0) | 0 (0) | 1 (<1) |
Most frequent adverse events a | |||
Nasopharyngitis | 9 (8) | 7 (6) | 12 (10) |
Headache | 10 (9) | 9 (8) | 5 (4) |
Oropharyngeal pain | 6 (5) | 2 (2) | 7 (6) |
Upper respiratory tract infection | 2 (2) | 2 (2) | 8 (7) |