Safety outcomes: adverse events and mortality
| Outcome | Disease management | Usual management |
| Subjects n | 157 | 162 |
| Patients with at least one adverse event | 139 (88.5) | 151 (93.2) |
| Total number of adverse events | 683 | 801 |
| Patients with adverse events that occurred in ≥3% of patients overall during follow-up | ||
| COPD exacerbation (any severity) | 113 (72.0) | 124 (76.5) |
| Pneumonia | 13 (8.3) | 13 (8.0) |
| Bronchitis | 10 (6.4) | 9 (5.6) |
| Nasopharyngitis | 8 (5.1) | 5 (3.1) |
| Dyspnoea | 4 (2.5) | 6 (3.7) |
| Acute cardiac failure | 4 (2.5) | 9 (5.6) |
| Back pain | 6 (3.8) | 6 (3.7) |
| Peripheral oedema | 3 (1.9) | 7 (4.3) |
| Patients with at least one SAE | 92 (58.6) | 101 (62.3) |
| Total number of SAEs | 267 | 312 |
| Patients with SAEs that occurred in ≥2% of patients overall during follow-up | ||
| COPD exacerbation | 67 (42.7) | 78 (48.1) |
| Pneumonia | 9 (5.7) | 10 (6.2) |
| Acute cardiac failure | 3 (1.9) | 7 (4.3) |
| Acute respiratory failure | 4 (2.5) | 3 (1.9) |
| Deaths during follow-up | 3 (1.9) | 23 (14.2)¶ |
| Fatal SAEs during follow-up | ||
| COPD exacerbation | 0 (0.0) | 13 (8.0) |
| Pneumonia | 0 (0.0) | 2 (1.2) |
| Acute respiratory failure | 0 (0.0) | 1 (0.6) |
| Respiratory failure | 1 (0.6) | 0 (0.0) |
| Hypercapnic coma | 0 (0.0) | 2 (1.2) |
| Hypoxic-ischaemic encephalopathy | 0 (0.0) | 1 (0.6) |
| Cardio-respiratory arrest | 1 (0.6) | 1 (0.6) |
| Bile duct cancer | 0 (0.0) | 1 (0.6) |
| Cholangiocarcinoma | 0 (0.0) | 1 (0.6) |
| Multi-organ failure | 0 (0.0) | 1 (0.6) |
| Biliary tract infection | 0 (0.0) | 1 (0.6) |
| Pneumothorax traumatic | 1 (0.6) | 0 (0.0) |
| Septic shock | 0 (0.0) | 1 (0.6) |
| Patients who discontinued because of an adverse event during follow-up# | 4 (2.5) | 23 (14.2) |
Data are presented as n (%). Results shown are for the intention-to-treat population. #: one patient was withdrawn for worsening depressive syndrome (non-fatal); ¶: p<0.001 (Chi-squared test). COPD: chronic obstructive pulmonary disease; SAE: serious adverse event.