Table 4. Incidence (events per patient-year) of the most common adverse events and selected adverse events commonly associated with β2-adrenoceptor-mediated effects, adjusted for length of time on treatment.
| Indacaterol 150 µg (n=2,611) | Tiotropium 18 µg (n=1,214) | Salmeterol 50 µg (n=895) | Placebo (n=2,012) | |
|---|---|---|---|---|
| Total patient-years | 859.72 | 357.97 | 274.93 | 923.60 |
| Most common adverse events (events per patient-year) | ||||
| COPD worsening | 0.46 | 0.48 | 0.35 | 0.67 |
| Cough | 0.17 | 0.16 | 0.08 | 0.12 |
| Dyspnea | 0.06 | 0.08 | 0.06 | 0.08 |
| Oropharyngeal pain | 0.05 | 0.08 | 0.04 | 0.03 |
| Nasopharyngitis | 0.22 | 0.24 | 0.19 | 0.22 |
| Upper RTI | 0.11 | 0.14 | 0.03 | 0.12 |
| Upper RTI bacterial | 0.06 | 0.05 | 0.02 | 0.09 |
| Lower RTI | 0.06 | 0.06 | 0.09 | 0.09 |
| Influenza | 0.05 | 0.06 | 0.03 | 0.04 |
| Bronchitis | 0.05 | 0.06 | 0.03 | 0.07 |
| Viral upper RTI | 0.05 | 0.04 | 0.02 | 0.05 |
| Headache | 0.18 | 0.18 | 0.14 | 0.10 |
| Muscle spasms | 0.10 | 0.02 | 0.06 | 0.04 |
| Arthralgia | 0.05 | 0.03 | 0.02 | 0.03 |
| Back pain | 0.05 | 0.06 | 0.06 | 0.06 |
| Adverse events associated with β2-adrenoceptor-mediated effects (events per patient-year) | ||||
| Insomnia | 0.02 | 0.02 | 0.05 | 0.03 |
| Anxiety | 0.02 | 0.01 | 0.02 | 0.02 |
| Tremor | 0.01 | 0.01 | 0.01 | 0.01 |
| Palpitations | 0.01 | 0.02 | 0.02 | 0.01 |
| Tachycardia | 0 | 0.01 | 0.01 | 0.01 |
RTI, respiratory tract infection.