Table S4.
AEs occurring in at least 5% of patients in any treatment group
| System organ class; preferred term (MedDRA) | Cic dose during baseline period (3 weeks); n (%)
|
Cic dose during randomized, double-blind period (52 weeks); n (%)
|
Total (all), n (%)
|
|||
|---|---|---|---|---|---|---|
| 160 μg/day (N=520) |
160 μg/day (N=119) |
320 μg/day (N=122) |
640 μg/day (N=126) |
Total (N=367) |
Total (N=520) |
|
| All AEs | 109 (21.0) | 85 (71.4) | 86 (70.5) | 89 (70.6) | 260 (70.8) | 301 (57.9) |
| Nervous system disorders | ||||||
| Headache | 43 (8.3) | 22 (18.5) | 23 (18.9) | 16 (12.7) | 61 (16.6) | 84 (16.2) |
| Infections and infestations | ||||||
| Nasopharyngitis | 6 (1.2) | 23 (19.3) | 25 (20.5) | 22 (17.5) | 70 (19.1) | 72 (13.8) |
| Bronchitis | 1 (0.2) | 18 (15.1) | 16 (13.1) | 16 (12.7) | 50 (13.6) | 51 (9.8) |
| Influenza | 0 | 6 (5.0) | 6 (4.9) | 11 (8.7) | 23 (6.3) | 23 (4.4) |
| Sinusitis | 1 (0.2) | 7 (5.9) | 5 (4.1) | 8 (6.3) | 20 (5.4) | 21 (4.0) |
| Rhinitis | 6 (1.2) | 2 (1.7) | 8 (6.6) | 4 (3.2) | 14 (3.8) | 18 (3.5) |
| Pharyngitis | 1 (0.2) | 4 (3.4) | 8 (6.6) | 4 (3.2) | 16 (4.4) | 17 (3.3) |
| Upper respiratory tract infection | 3 (0.6) | 7 (5.9) | 1 (0.8) | 6 (4.8) | 14 (3.8) | 15 (2.9) |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Rhinitis allergic | 3 (0.6) | 8 (6.7) | 3 (2.5) | 6 (4.8) | 17 (4.6) | 20 (3.8) |
| Asthma | 4 (0.8) | 4 (3.4) | 8 (6.6) | 4 (3.2) | 16 (4.4) | 19 (3.7) |
| Cough | 2 (0.4) | 6 (5.0) | 7 (5.7) | 3 (2.4) | 16 (4.4) | 18 (3.5) |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3 (0.6) | 4 (3.4) | 2 (1.6) | 8 (6.3) | 14 (3.8) | 17 (3.3) |
Notes: MedDRA version 16.1. Data are n (%) in the safety analysis set. A notably lower number of AEs were reported in the baseline period (21%) compared with the randomized period (~71%) due to a baseline period of 3 weeks (randomized period was 52 weeks). Patients may have had more than one AE. n, number of patients with an event; %, percentage of patients with at least one event based on N.
Abbreviations: AE, adverse event; Cic, ciclesonide.