Table S4.
Number (%) of patients who had an adverse event (AE) in any category in the 12-month budesonide/formoterol vs placebo pool (Calverley et al and Szafranski et al studies only)1,2
| Category of AE | Budesonide/formoterol (n=462) |
Placebo (n=461) |
|---|---|---|
| Any AE | 284 (61.5) | 270 (58.6) |
| Serious AEs | 93 (20.1) | 88 (19.1) |
| Serious AEs leading to death | 10 (2.2) | 10 (2.2) |
| Serious AEs not leading to death | 85 (18.4) | 80 (17.4) |
| Discontinuation of study treatment due to AEs | 81 (17.5) | 119 (25.8) |
Notes: Safety population includes all patients who received at least one dose of treatment. This table includes patients with AEs onset during randomized treatment. Patients with multiple events in the same category are counted only once in that category. Patients with events in >1 category are counted once in each of those categories.