Table 3.
Frequency of TEAEs Overall and Occurring in ≥2 Patients, by MedDRAa Preferred Term (Safety Population)
| TEAE (Preferred Terma) | Placebo (n = 32) | navafenterol 400 μg (n = 34) | navafenterol 1800 μg (n = 31) | Indacaterol 150 μg (n = 32) | Tiotropium 18 μg (n = 30) | All (N = 38) |
|---|---|---|---|---|---|---|
| Any event, n (%) | 11 (34.4) | 18 (52.9) | 7 (22.6) | 12 (37.5) | 11 (36.7) | 31 (81.6) |
| Headache | 7 (21.9) | 5 (14.7) | 3 (9.7) | 4 (12.5) | 7 (23.3) | 12 (31.6) |
| Nasopharyngitis | 1 (3.1) | 1 (2.9) | 1 (3.2) | 2 (6.3) | 1 (3.3) | 5 (13.2) |
| COPD | 0 | 2 (5.9) | 1 (3.2) | 1 (3.1) | 0 | 4 (10.5) |
| Erythema | 1 (3.1) | 1 (2.9) | 0 | 1 (3.1) | 0 | 3 (7.9) |
| Medical device site reaction | 1 (3.1) | 0 | 1 (3.2) | 1 (3.1) | 0 | 3 (7.9) |
| Constipation | 1 (3.1) | 1 (2.9) | 1 (3.2) | 0 | 0 | 2 (5.3) |
| Nausea | 1 (3.1) | 1 (2.9) | 0 | 0 | 0 | 2 (5.3) |
| Rhinitis | 0 | 1 (2.9) | 0 | 1 (3.1) | 0 | 2 (5.3) |
COPD chronic obstructive pulmonary disease, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment emergent adverse event.
aMedDRA version 18.1