UMEC | GLYCO | |
Patients n | 516 | 518 |
Adverse event category | ||
Any on-treatment adverse event | 193 (37) | 188 (36) |
Any on-treatment drug-related adverse event# | 17 (3) | 18 (3) |
Any on-treatment non-fatal SAE | 15 (3) | 13 (3) |
Any on-treatment non-fatal drug-related SAE# | 1 (<1) | 0 |
Any on-treatment fatal SAE | 2 (<1) | 2 (<1) |
On-treatment AE reported by ≥3% of subjects in either group by preferred term | ||
Headache | 42 (8) | 51 (10) |
Nasopharyngitis | 42 (8) | 39 (8) |
Non-fatal SAE reported by ≥2 patients by preferred term | ||
COPD¶ | 7 (1) | 5 (<1) |
Pneumonia | 2 (<1) | 0 |
Atrial fibrillation | 1 (<1) | 1 (<1) |
AE of special interest by preferred term | ||
Cardiovascular events | 12 (2) | 11 (2) |
Pneumonia | 4 (<1) | 4 (<1) |
LRTI excluding pneumonia | 5 (<1) | 6 (1) |
Data are presented as n (%), unless otherwise stated. #: drug-related adverse events (AEs) or severe adverse events (SAEs) were defined by the study investigator; ¶: chronic obstructive pulmonary disease (COPD) was listed as an AE by the participating investigator and was likely due to a worsening of the underlying condition. GLYCO: glycopyrronium; UMEC: umeclidinium; LRTI: lower respiratory tract infection.