Asthma-related and cardiac-related serious adverse events (SAEs) across randomised controlled trials stratified by any inhaled corticosteroid (ICS) use at baseline
| Formoterol | No Formoterol | RR (95% CI)# | |||||
| Patientsn | Follow-up TPY | Patients with SAEs¶ n (%) | Patientsn | Follow-up TPY | Patients with SAEs n (%) | ||
| Asthma-related SAEs | |||||||
| All subjects | 49906 | 23.6 | 374 (0.75) | 18098 | 9.2 | 199 (1.10) | 0.68 (0.57–0.81) |
| With ICS | 46003 | 21.7 | 346 (0.75) | 13905 | 7.2 | 166 (1.19) | 0.63 (0.52–0.76) |
| No ICS | 3903 | 1.9 | 28 (0.72) | 4193 | 2.1 | 33 (0.79) | 0.91 (0.53–1.56) |
| Cardiac-related SAEs | |||||||
| All subjects | 49906 | 23.6 | 103 (0.21) | 18098 | 9.2 | 45 (0.25) | 0.83 (0.58–1.20) |
| With ICS | 46003 | 21.7 | 95 (0.21) | 13905 | 7.2 | 38 (0.27) | 0.76 (0.51–1.13) |
| No ICS | 3903 | 1.9 | 8 (0.20) | 4193 | 2.1 | 7 (0.17) | 1.23 (0.39–3.98) |
SAEs defined using International Conference on Harmonisation recommendations. RR: rate ratio; CI: confidence interval; TPY: 1,000 person-yrs. #: for the odds ratio for asthma-related and cardiac-related SAEs (for formoterol versus non-long-acting β2-agonist) 28, as calculated using StatXact 8.0.0 (Cytel® Inc., Cambridge, MA, USA) 27; ¶: at least one nonfatal SAE per patient.