Table 3. Summary of on-treatment AEs.
| UMEC+ICS/LABA (N=119) | PBO+ICS/LABA (N=117) | |
|---|---|---|
| Any on-treatment AE, n (%) | 45 (38) | 49 (42) |
|
Most common on-treatment AEs reported by ⩾3% of patients in any treatment group by study, n (%)
| ||
| Nasopharyngitis | 16 (13) | 17 (15) |
| Headache | 4 (3) | 8 (7) |
| Cough | 3 (3) | 5 (4) |
| Back pain | 2 (2) | 5 (4) |
| Pneumonia | 3 (3) | 2 (2) |
| Chest Pain | 0 | 3 (3) |
| Diarrhoea | 3 (3) | 0 |
| Oropharyngeal Pain | 0 | 3 (3) |
| Upper Respiratory Tract Infection | 3 (3) | 0 |
| Any on-treatment non-fatal drug-related SAEs, n (%) | 0 | 0 |
| Any on-treatment fatal drug-related SAEs, n (%) | 0 | 0 |
| Any on-treatment non-fatal SAEs, n (%) | 6 (5) | 4 (3) |
| Any on-treatment fatal SAEs, n (%) | 0 | 1 (<1)a |
| Any on-treatment AEs leading to permanent discontinuation of medication/withdrawal, n (%) | 7 (6) | 3 (3) |
| Number of patients with a COPD exacerbation, n (%) | 17 (14) | 16 (14) |
Abbreviations: AE, adverse event; COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; PBO, placebo; SAE, serious adverse event; UMEC, umeclidinium.
a
There was one death in the group on Day 23; this was not drug-related (road traffic accident).