Table 3 On-treatment AEs occurring in ≥3% of patients in any treatment group (ITT population)
Placebo (N =143) n (%) | UMEC 31.25 mcg (N =139) n (%) | UMEC 62.5 mcg (N =139) n (%) | |
|---|---|---|---|
Any AE | 65 (45) | 73 (53) | 57 (41) |
Nasopharyngitis | 17 (12) | 14 (10) | 13 (9) |
Upper respiratory tract infection | 3 (2) | 8 (6) | 6 (4) |
Respiratory tract infection viral | 5 (3) | 7 (5) | 4 (3) |
Oropharyngeal pain | 2 (1) | 6 (4) | 4 (3) |
Dysphonia | 2 (1) | 6 (4) | 0 |
Headache | 11 (8) | 9 (6) | 12 (9) |
Toothache | 4 (3) | 1 (<1) | 5 (4) |
Back pain | 5 (3) | 3 (2) | 1 (<1) |
Arthralgia | 1 (<1) | 5 (4) | 2 (1) |
Hypertension | 5 (3) | 4 (3) | 1 (<1) |
Drug-related AEs | 4 (3) | 6 (4) | 3 (2) |
AEs leading to permanent discontinuation of study treatment | 1 (<1) | 1 (<1) | 1 (<1) |
AEs leading to withdrawal from the study | 1 (<1) | 0 | 0 |
Any SAE | 5 (3) | 4 (3) | 3 (2) |
Drug-related SAEs | 0 | 0 | 0 |
Fatal SAEs | 0 | 0 | 0 |
Fatal drug-related SAEs | 0 | 0 | 0 |