Table 4 Summary of on-treatment AESIs (ITT population)
Placebo (N =143) n (%) | UMEC 31.25 mcg (N =139) n (%) | UMEC 62.5 mcg (N =139) n (%) | |
|---|---|---|---|
Adrenal suppression | 0 | 0 | 0 |
Anticholinergic syndrome (SMQ)* | 1 (<1) | 1 (<1) | 3 (2) |
CV effects* | 10 (7) | 7 (5) | 6 (4) |
Hypertension (SMQ) | 7 (5) | 5 (4) | 4 (3) |
Cardiac arrhythmia | 1 (<1) | 1 (<1) | 1 (<1) |
Ischaemic heart disease (SMQ) | 1 (<1) | 0 | 1 (<1) |
Cardiac failure (SMQ) | 1 (<1) | 1 (<1) | 0 |
CNS haemorrhages and cerebrovascular conditions (SMQ) | 1 (<1) | 0 | 0 |
Decreased BMD and associated fractures | 0 | 0 | 0 |
Dry mouth/drying of the airway secretions (broad focus)* | 28 (20) | 29 (21) | 27 (19) |
Dry mouth/drying of the airway secretions (narrow focus)* | 0 | 0 | 1(<1) |
Gastrointestinal obstruction (SMQ)* | 0 | 0 | 0 |
Hyperglycaemia/ new onset diabetes mellitus (SMQ) | 1 (<1) | 0 | 0 |
Hypersensitivity* | 3 (2) | 3 (2) | 1 (<1) |
Infective pneumonia (SMQ)* | 1 (<1) | 1 (<1) | 0 |
LRTI (excluding infective pneumonia SMQ)* | 3 (2) | 2 (1) | 6 (4) |
Local steroid effects | 5 (3) | 12 (9) | 6 (4) |
Ocular effects* | 0 | 1 (<1) | 0 |
Glaucoma (SMQ) | 0 | 1 (<1) | 0 |
Lens disorders (SMQ) | 0 | 0 | 0 |
Urinary retention* | 1 (<1) | 0 | 0 |