Table S6.
Number (%) of patients with most common adverse events (AEs) (frequency of ≥2% in any treatment group) in the 12-month budesonide/formoterol vs placebo pool (Calverley et al and Szafranski et al studies only)1,2
| Preferred term | Budesonide/formoterol (n=462) |
Placebo (n=461) |
|---|---|---|
| Chronic obstructive pulmonary disease | 84 (18.2%) | 125 (27.1%) |
| Nasopharyngitis | 42 (9.1%) | 27 (5.9%) |
| Headache | 15 (3.2%) | 10 (2.2%) |
| Pneumonia | 14 (3.0%) | 11 (2.4%) |
| Chest pain | 16 (3.5%) | 8 (1.7%) |
| Dyspnoea | 8 (1.7%) | 15 (3.3%) |
| Back pain | 9 (1.9%) | 9 (2.0%) |
| Muscle spasms | 14 (3.0%) | 4 (0.9%) |
| Respiratory tract infection | 10 (2.2%) | 7 (1.5%) |
| Diarrhoea | 9 (1.9%) | 6 (1.3%) |
| Influenza | 11 (2.4%) | 2 (0.4%) |
| Rhinitis | 10 (2.2%) | 3 (0.7%) |
| Insomnia | 7 (1.5%) | 5 (1.1%) |
| Myalgia | 8 (1.7%) | 3 (0.7%) |
| Dysphonia | 9 (1.9%) | 1 (0.2%) |
| Pharyngitis | 5 (1.1%) | 5 (1.1%) |
| Pyrexia | 8 (1.7%) | 2 (0.4%) |
| Dyspepsia | 8 (1.7%) | 1 (0.2%) |
| Vomiting | 5 (1.1%) | 1 (0.2%) |
Notes: This table includes patients with AEs onset during randomized treatment. Patients with multiple AEs coded to the same preferred term are counted only once for that preferred term.