Table 4.
Summary of AEs
| ITT population | MN population | |||
|---|---|---|---|---|
| UMEC/VI (N = 878) |
TIO (N = 869) |
UMEC/VI (N = 275) |
TIO (N = 258) |
|
| AEs reported by ≥3% of patients on any treatment, n(%) | ||||
| Nasopharyngitis | 63 (7) | 62 (7) | 18 (7) | 15 (6) |
| Headache | 80 (9) | 55 (6) | 20 (7) | 15 (6) |
| Back pain | 27 (3) | 28 (3) | 8 (3) | 4 (2) |
| Cough | 25 (3) | 26 (3) | 5 (2) | 8 (3) |
| Upper respiratory tract infection | 17 (2) | 26 (3) | 2 (<1) | 10 (4) |
| AEs of special interest | ||||
| Cardiovascular events (any) | 2 (<1) | 2 (<1) | 0 | 1 (<1) |
| Pneumonia | 2 (<1) | 6 (<1) | 0 | 1 (<1) |
| On-treatment non-fatal SAEs | ||||
| Any event, n(%) | 42 (5) | 35 (4) | 8 (3) | 11 (4) |
| Fatal AEsa | ||||
| Any event, n(%) | 4 (<1) | 7 (<1) | 3 (1) | 2 (<1) |
AE adverse event, COPD chronic obstructive pulmonary disease, ITT intent to treat, MN maintenance-naïve, SAE serious adverse event, TIO tiotropium, UMEC umeclidinium, VI vilanterol
aDeaths were attributable to the following: ITT: cardiac arrest, cardiac failure, COPD, and hemorrhagic stroke in the UMEC/VI group; cardiac failure, pulmonary embolism, respiratory arrest, respiratory failure, upper gastrointestinal hemorrhage, sudden death, and pancreatic carcinoma in the TIO group. MN: Cardiac arrest, hemorrhagic stroke, and COPD in the UMEC/VI group; respiratory arrest and respiratory failure in the TIO group